224 Fda Jobs - Page 9

Develop, implement, and maintain quality standards and inspection criteria for raw materials, in-process production, and finished products. Monitor production processes to ensure compliance with quality standards

Senior JDE CNC Consultant Full-time DepartmentEnterprise Applications Company Description Version 1 has celebrated over 26 years in Technology Services and continues to be trusted by global brands to deliver solutions that drive customer success. Version 1 has several strategic technology partners including Microsoft, AWS, Oracle, Red Hat, OutSystems and Snowflake. Were also an award-winning employer reflecting how employees are at the heart of Version 1. Weve been awardedInnovation Partner of the Year Winner 2023 Oracle EMEA Partner Awards, Global Microsoft Modernising Applications Partner of the Year Award 2023, AWS Collaboration Partner of the Year - EMEA 2023 and Best Workplaces for Women by Great Place To Work in UK and Ireland 2023. As a consultancy and service provider, Version 1 is a digital-first environment and we do things differently. Were focused on our core values; using these weve seen significant growth across our practices and our Digital, Data and Cloud team is preparing for the next phase of expansion. This creates new opportunities for driven and skilled individuals to join one of the fastest-growing consultancies globally. About The Role Version 1 is currently seeking a JD Edwards CNC Consultant to join our team. This job will be within projects team at Version 1, and it is focused on the technical support of JDE Edwards installation and upgrade projects. The candidate will be expected have sufficient experience in JDE Tools and Application Updates, JDE release upgrades and new installs. The candidate will also be expected to be able to manage tickets within the managed service for various issues with key skills being the ability to manage and administrate JDE environments with tasks such as system checks, package builds, patches and upgrades, troubleshoot issues, and provide technical support to end-users. Responsibilities Lead CNC tasks in JDE Tools and Application updates. Responsible for end-to-end JDE installation and JDE Release updates Support project activities and assist developers and functional team members Support users in resolving technical problems and answer inquiries related to JD Edwards functionality. Perform regular system maintenance tasks, including applying patches, updates, and fixes. Collaborate with developers and functional consultants to implement customizations and enhancements. Create and maintain documentation related to CNC procedures, configurations, and troubleshooting steps. Participate in training sessions to enhance technical skills and understanding of JD Edwards modules. Assist in implementing security measures and ensuring compliance with company policies and industry regulations. Support data management tasks, data migrations and SQL scripts Stay updated with the latest JD Edwards releases, features, and best practices Qualifications Bachelors degree in computer science, Information Technology, or a related field is required. 5+ years of hands-on JD Edwards CNC project exposure. Basic project management skills/experience Strong analytical and problem-solving skills. Excellent communication, interpersonal, and presentation skills. Ability to work collaboratively in a fast-paced environment. Willingness to learn new technologies and adapt to changing requirements. Attention to detail and ability to follow procedures accurately. Basic understanding of database management systems such as Oracle and SQL Experienced in administration and support of WebLogic/WebSphere middleware and JDE BSSV Knowledge of Linux/Microsoft/AS400 operating systems is required. Familiarity with OCI Cloud is a plus. Additional Information At Version 1, we believe in providing our employees with a comprehensive benefits package that prioritises their well-being, professional growth, and financial stability. One of our standout advantages is the ability to work with a hybrid schedule along with business travel, allowing our employees to strike a balance between work and life. We also offer a range of tech-related benefits, including an innovative Tech Scheme to help keep our team members up-to-date with the latest technology. We prioritise the health and safety of our employees, providing private medical and life insurance coverage, as well as free eye tests and contributions towards glasses. Our team members can also stay ahead of the curve with incentivized certifications and accreditations, including AWS, Microsoft, Oracle, and Red Hat. Our employee-designed Profit Share scheme divides a portion of our company's profits each quarter amongst employees. We are dedicated to helping our employees reach their full potential, offering Pathways Career Development Quarterly, a programme designed to support professional growth. #LI-SJ1 Cookies Settings

We are seeking a highly skilled and motivated Process Engineer to join our team at Morepen Laboratories Ltd, a leading organization dealing in manufacturing of home diagnostics medical devices. The Process Engineer will play a crucial role in optimizing manufacturing processes, ensuring product quality, and driving continuous improvement initiatives. This role requires a strong understanding of manufacturing principles, medical device regulations, and process improvement methodologies. Role & responsibilities Process Optimization: * Analyze and optimize manufacturing processes to improve efficiency, reduce costs, and enhance product quality. * Develop, implement, and validate process improvements, including new equipment, procedures, and technologies Technical Support: * Provide technical support to production teams to resolve process issues, equipment malfunctions, and quality concerns. * Collaborate with cross-functional teams, including R&D, quality assurance, and production, to ensure smooth integration of new products and processes. Compliance and Documentation: * Ensure all processes comply with regulatory requirements, including FDA, ISO 13485, and other relevant standards. * Develop and maintain process documentation, including Standard Operating Procedures (SOPs), Work Instructions, and Process Flow Diagrams. Process Development: * Design and execute process validation studies, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). * Identify and implement best practices for process design, control, and monitoring Preferred candidate profile Qualifications: Education: Bachelors degree in Engineering (Electrical, ECE). Advanced degree or certifications (e.g., Six Sigma, Lean) preferred. Experience: Minimum of [3-5] years of experience in process engineering within a medical device or regulated manufacturing environment. Perks and benefits

Key Responsibilities: Manual Tester [Experience 6-10 yrs] Create and execute detailed test cases using software requirements and specifications. Experience with Medical device testing or knowledge of relevant regulatory standards Familiarity with various types of testing Functional, Regression, Integration, etc. Experience with bug tracking tools like JIRA, Azure DevOps. Identify, document and report bugs and issues and track defect status. Create and maintain test documentation, including test plans, test cases and reviewing of test documentation. Update test cases and documentation as required based on changes in requirements or application functionality. Experience in estimating and planning software Testing projects Experience with version control systems Experience in testing standalone Windows based applications and Virtual environments (for ex. VMWare, Oracle VMVirtualBox) Ability to work independently as well as part of team. Good to Have: Effective communication skills, both written and verbal. Experience in testing standalone Windows based applications and Virtual environments (for ex. VMWare, Oracle VMVirtualBox) Familiarity with Agile / Scrum methodologies. Experience with Automation testing tools or scripting is a plus. (FDA, ISO 13485) is a plus. Experience with Ranorex tool Knowledge of Python scripting. About The Role Manual Tester [Experience 6-10 yrs] Create and execute detailed test cases using software requirements and specifications. Experience with Medical device testing or knowledge of relevant regulatory standards Familiarity with various types of testing Functional, Regression, Integration, etc. Experience with bug tracking tools like JIRA, Azure DevOps. Identify, document and report bugs and issues and track defect status. Create and maintain test documentation, including test plans, test cases and reviewing of test documentation. Update test cases and documentation as required based on changes in requirements or application functionality. Experience in estimating and planning software Testing projects Experience with version control systems Experience in testing standalone Windows based applications and Virtual environments (for ex. VMWare, Oracle VMVirtualBox) Ability to work independently as well as part of team. Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders. About The Role - Grade Specific Good to Have: Effective communication skills, both written and verbal. Experience in testing standalone Windows based applications and Virtual environments (for ex. VMWare, Oracle VMVirtualBox) Familiarity with Agile / Scrum methodologies. Experience with Automation testing tools or scripting is a plus. (FDA, ISO 13485) is a plus. Experience with Ranorex tool Knowledge of Python scripting. Skills (competencies) Verbal Communication

About The Role Support and Maintenance of customers Adobe Campaign Classic platform Responsible for handling tickets in Production environment Perform RCA on recurring issue and provide permanent fixes Monitoring of the workflow and taking corrective actions Coordination of system-related activities between user and multiple technical teams Responsible for the upkeep and maintenance of Adobe Campaign application servers and coordination with DBA's Understanding integration of Adobe with other applications. Primary Skills 4 to 5 years of support and development experience with Adobe Campaign Classic (Neolane) Experience in working with different Adobe Campaign modules, like; Message Centre, Content Manager, FDA, etc. knowledge and experience with the following programming languagesHTML, XML, JavaScript and SQL Knowledge and experience of integrating Adobe Campaign with other system Basic knowledge on SQL and Unix Good communication and interpersonal skill and willing to travel if required as this roles involves directly working with end customer. Secondary Skilla Good to have Certification

We are seeking a skilled Analyst with hands-on experience in HPLC or GC or ICP techniques. The candidate should be well versed with Method Development, Method Validation and Method Transfer. Required Candidate profile It is on the rolls of Cotecna Life Sciences India Pvt Ltd(Erstwhile Geochem Laboratories) If interested please share profiles on nilesh.kadam@geochem.net.in or any more information call on 9870476784

Looking for a challenging role? If you want to make a difference - make it with us Can we energize society and fight climate change at the same time? At Siemens Energy, we can. Our technology is key, but our people make the difference. Brilliant minds innovate. They connect, create, and keep us on track towards changing the world"™s energy systems. Their spirit fuels our mission. Our culture is defined by caring, agile, respectful, and accountable individuals. We value excellence of any kind. Sounds like you? We make real what matters. This is your role As an Engineering specialist, design control philosophy and wiring schematics for EHV and HV AIS circuit breakers. Responsible for preparing engineering documents, discussions with customers regarding open points, and arranging drawing approvals by conducting meetings/customer visits to customers like PGCIL, NTPC, and other major utilities. Take handover from the Sales/Order Acquisition team and understand all documents and specifications to provide engineering documents in line with agreed technical parameters. Checking and maintaining/configuring SAP BOM for all Circuit Breaker and spare orders. Spares and internal order booking/customer complaints booking in SAP and maintaining bill of material. Understanding non-standard requirements and circulating correct information about the drawings through manufacturing instructions. Engage with internal stakeholders to clear all engineering documents, Bills of materials, SAP codes, etc. What you need to make real what matters You should be a graduate/postgraduate in Electrical engineering, have sufficient product knowledge, and 3 to 5 years of industry experience. You should have Strong strategic planning, negotiation, customer intimacy, organizational skills, proactiveness, strong decision-making, ownership mindset, and soft skills. Excellent analytical and problem-solving skills with the ability to manage multiple disciplines simultaneously. Knowledge of Auto CAD, E-Plan, CAD Worx E&I, and SAP. You"™ve good knowledge of High Voltage Circuit breakers of Air Insulated Substations. We"™ve got quite a lot to offer. How about you? This role is based in " Aurangabad ". You"™ll also get to visit other locations in India and beyond, so you"™ll need to go where this journey takes you. In return, you"™ll get the chance to work with teams impacting entire cities, countries and the shape of things to come. We"™re Siemens. A collection of over 379,000 minds building the future, one day at a time in over 200 countries. We're dedicated to equality, and we welcome applications that reflect the diversity of the communities we work in. All employment decisions at Siemens are based on qualifications, merit, and business needs. Bring your curiosity and imagination and help us shape tomorrow.

Job title manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Reports to Head of Quality Assurance (GMP and GCP) Job purpose Our Quality team is growing, and we are currently seeking a Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our clinical and commercial manufacturing processes. Reporting to the Head of QA, the Manager will oversee a team responsible for manufacturing, batch record release, investigations, deviations, CAPAs (Corrective and Preventive Actions), change controls, analytical methods, stability programs, and auditing within our GMP operations. Duties and responsibilities QA managers define and implement quality standards for products or services. Author or review Ocugen quality standards, procedures, and work instructions. Participate in cross - functional teams to establish and enhance the quality systems and support for managing high levels of quality compliance at contract manufacturers. Build strategic relationships with CDMOs (Contract Development and Manufacturing Organization) within the Quality organization and participate in Business Review Meetings to ensure Quality issues are identified, managed, addressed, and escalated, as necessary. Establish, maintain , and monitor supplier files including Quality Agreements with CDMOs and directly related suppliers to the CDMOs. Responsible for the quality review and approval of master batch records, executed batch records, reports, protocols, analytical methods, change controls, investigations, OOS (Out of Specifications), OOT (Out of Trends), deviations, and CAPA for development, clinical and commercial processes, assess impact and provide quality oversight of implementation activities. Support RCA (Root Cause Analysis and associated tools) and product impact assessments for investigations resulting from deviations and OOS events. Oversee, review, and approve quality testing processes and identify gaps in testing. Oversee, review, and approve manufacturing processes and identify gaps in manufacturing. Overseeing, reviewing, and approving quality events and ensuring effectiveness is part of business improvements. Staying up to date with relevant laws and regulations to ensure compliance. Train other employees in quality standards and procedures and handle quality reports, documentation, and records. Collect and analyze QA data and prepare monthly and quarterly metrics regularly. Work with GMP vendors to ensure their quality and conduct vendor audit if necessary. Participate in internal audit program and followup on CAPA (Corrective and Preventive Actions) assigned to closure within the timeframe. Eliminating products that are not up to standards and finding the reasons for product problems Identify potential risks before they become a problem, focusing on root cause analysis and preventive action Identify opportunities for process improvements and efficiencies within the QA Operations function, driving continuous improvement initiatives. Qualifications: Bachelor' or Masters in Biology, Chemistry, or related fields. At least eight (8) years for BS and five (5) years for MS GMP experience with a focus on quality with substantial operational and GMP experience supporting Biologics/Vaccines/Cell and gene therapy products. At least five (5) years in roles of increasing management responsibility in a biopharmaceutical environment; at least two (2) years managing Phase 1-3 clinical trials. Prior experience and a broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory required. In-depth knowledge of the international regulatory landscape is preferred. In-depth knowledge of and ability to interpret and apply GMP EU, FDA (Food and Drug Administration), USP (United States Pharmacopeia), Phr. Eu., WHO, PMDA, and ICH regulations and guidelines. Excellent written, verbal, listening, and interpersonal communication skills. Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants, and contractors). Integrated Quality leader who can build strong collegial relationships cross-departmentally while effectively and courageously driving regulatory compliance. Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment. Proven background in GxP and GMP audit management, risk management, mitigation, and controls. Proficient in Veeva Vault systems (QualityDocs, Training, eQMS, RIM, etc.). Working conditions This position operates primarily in an office setting and may include 10% of travel. This position is in Hyderabad, INDIA (on-site). This position will work in US business hours. Physical requirements This is a sedentary role.

About The Role : Job TitleRegulatory Control Analyst LocationBangalore, India Role Description The candidate for the AFC Centre of Excellence for KYC is supporting CB and IB KYC escalations to AFC, collaborating with the relevant Business stakeholders, Client Lifecycle Management and other AFC functions. Primary focus of the reviewer would be to ensure they review and approve the risk factor highlighted by CLM team as part of NCA/EDR/PRs Organization Deutsche Bank (DB) is committed to the highest standards of Anti-Money Laundering (AML), Sanctions & Embargoes, Anti-Bribery and Corruption (ABC) and Anti-Fraud & Investigations (AF&I) and wider Financial Crime (collectively referred to as Anti Financial Crime) prevention. The Management and all employees are required to adhere to these standards to prevent DB and our reputation from those who may intend to use our products and services for money laundering, bribery, corruption, fraud and/or Terrorist Financing (TF) purposes. AFC KYC COE Implement a dedicated Centre(s) of Excellence for the AFC element of the KYC file review, allowing customers to be reviewed once in review cycle. Below are some of the key principals . Achieve economies of scale through the creation of one functional team with sophisticated risk managers, under one global leader who is accountable for the AFC KYC file review and sign-off process.Ensure fulfilment of local regulations and regulatory expectations in an efficient, risk focused manner.Ensure sufficient resources to create and effectively maintain a follow the sun KYC file review aligned with ACO availability.Seek opportunities to geographically co-locate the CoE with respective 1LoD counterparties (i.e. align with the 1LoD Target Operating Model) to stimulate cooperation and strengthen the relationship What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Review and approve client escalations for Remediation, Regular Review, New Product Extensions and Event Driven Reviews within the agreedSLAs Ensure the generated client risk rating is in line withexpectations & procedures. Assess the risk factors identified through the due diligence provided by client lifecycle management (CLM) Apply subject matter expertise judgment as to relevance and/or materiality of Escalation triggers; i.e., can the overall assessment bedefended Engage with appropriate BLAFC specialist team where further escalation is required e.g., local BLAFC, AFBC, Sanctions, BIUetc. Liaise with CLM to obtain additional information or request ACO to conduct additional research whererequired Ensure outcome and rational is clearly documented within the KYC systems and / or escalated for furtherguidance Ensure that KYC reviews undertaken are in line with the KOPs guidelines andprocesses Contributing to the wider globalKYCCentre of Excellence programme, identifying best practices Deciding on new or existing clients that are escalated or deciding to escalate further to Governance Forums for review. Defining and implementing strategic TOM in-line with local/regional/global standards and change programmes. Your skills and experience Skills: Ability to identify and manage financial crime risks arising from regular reviews, event driven reviews, new client adoptions and new productextensions Strong communication, organizational, and interpersonal skills with the confidence to engage and advise professionally and persuasively with stakeholders. Proven analytical skills, problem solving ability, and a control mindset paired with meticulous attention to detail. Able to raise sensitive or potentially contentious issues in a constructive manner to reach appropriate solutions. Deadline driven with the ability to multi-task and work in a fast-paced environment. Ability to handle time-sensitive projects while focusing on the quality of work delivered. Self-motivated and proactive team player who takes ownership of assignments, thrives in a teamwork-oriented environment, and works well under pressure. Ability to work with various stakeholders across all 1LoD and 2Lod and manage expectations, without impacting the quality output. Experience Must be a graduate with any stream with at least 2-3 years experience in AFC or a related control related function within an international organization/bank in the Financial Services industry with extensive experience with the KYC process. People having a degree or diploma in AML/KYC will be preferred. A strong track record in risk and regulatory matters, ideally including: Good understanding of AFC risks and typologies in order to identify areas or instances of potential AFC risks and to address them appropriately. Experience of relevant regulations/laws and related circulars Financial Crime function expertise and should be considered a Subject Matter Expert (SME) in the Financial Crime area on relevant laws and regulations. Should be flexible with respect to work timings. Should be comfortable in working on MS Office tools using word and excel. How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs

About The Role : Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency, and Depositary Receipts. OverviewTeam: TAS Analytics group within Corporate Trust business of Deutsche Bank is supporting the Structured Finance products like ABS/MBS/CDOs and other Debt products like Syndicated Loan transactions where DB acts as Trustee and/or Agent. As Trustee and/or Agent, DB is responsible for performing various calculations including but not limited to Bond Payments and Tax Calculations for new and existing bond issuances. Group has exposure to Corporate Trusts business in understanding the Structured Finance and other Debt products and its Analytics requirements along with supporting the CSG activities. The successful candidate will be required to cover European working hours supporting the EMEA/Americas business. Corporate title will depend on the relative experience of candidate. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Flexible working arrangements Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Read and interpret governing legal and issuer documents namely Prospectuses/Offering Circulars, Bond Indentures and Pooling and Servicing Agreements, Hedging Agreements, etc. Process and review Bond Payments for MBS, ABS, CDO and similar kinds of structured product deals in an In-House platform (iMAKE) based on the Offering Circulars/Indenture/Pooling & Servicing Agreement and using the best practices followed in the Group. Offer the highest level of customer service by understanding overall deal structure and bond payments to provide internal and external clients with explanations to support cash flow model output. Establish the guidelines for receipt and appropriate format of underlying asset-level collateral that supports bond payments, as well as research and resolve any data accuracy issues. Involvement in ad hoc/special projects which support process improvement and the implementation of technology initiatives. Understand and analyze issues and offer practical solutions. Working independently with a minimal degree of supervision is required to exercise independent judgment. Your skills and experience Bachelor of Science/Engineering or qualified CA/CFA with a high GPA and a minimum of 2 years of professional experience. Previous experience in developing cash flow models, and exposure to securities industry. Must have proven skills in MS Excel and/or MS Access with good scripting skills in VBA. Experience in using SQL Demonstrated ability to handle multiple and often competing projects under tight deadlines and pressure. Must project a Customer/Client service focus. Responsible for supporting efforts to mitigate and control operational risk. Must be organized, focused, and possess strong communication and analytical skills. Demonstrated ability to work and think independently, while supporting team goals/objectives. How we'll support you Training and development to help you excel in your career Flexible working to assist you balance your personal priorities Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for regulatory submissions to FDA and other global health authorities. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Maintain accurate records of all regulatory correspondence, reports, and audit findings. Ensure compliance with regulatory guidelines and requirements by reviewing documentation and conducting internal audits. Provide support during regulatory audits by gathering necessary information and preparing responses. Desired Candidate Profile 1-4 years of experience in Regulatory Affairs or related field (pharmaceutical industry). Bachelor's degree in Pharmacy (B.Pharma) or Science (B.Sc), preferably in a relevant specialization. Strong understanding of FDA regulations, regulatory operations, compliance, submissions, documentation, guidelines, issues, reports.

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions. Roles & Responsibilities: Participate in technical discussions related to the RBSE system(s) within Clinical Trial Management, Monitoring, and Engagement (CTMME) product team. Build technical solution per implementation project plan by working with various members of the product team and business partners. Conduct user acceptance testing with the customer, including coordination of all feedback, resolution of issues, and acceptance of the study Support requirements gathering and specification creation process for the development work. Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements Participate and contribute to process product or standard methodologies initiatives and support developers and testers during the project lifecycle. Define, author, and present various architecture footprints i.e. Business, Logical, Integration, Security, Infrastructure, etc. Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. Identify and resolve technical challenges/bugs effectively . Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science Bachelor’s degree with 6 - 8 years of experience in Computer Science Diploma with 10 - 12 years of experience in Computer Science. Preferred Qualifications: Solid technical background, including understanding software development processes, databases, and cloud-based content systems. Experience with Python scripting, SQL queries, markup languages (XML, JSON) and familiarity with API-driven content delivery. Agile/Scrum experience with demonstrated success managing product backlogs and delivering iterative product improvements. Experience with product backlog management (e.g., Jira) and collaboration tools. Good-to-Have Skills: Experience with structured content management, content models, and modular content creation. Understanding of international pharmaceutical regulatory submission guidelines and processes (eCTD, ICH, CDS, USPI etc.) Basic understanding of GenAI solutions. Good communication skills, with the ability to convey complex technical concepts. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

We have an urgent requirement for the BDM who has working in Cosmetic Industry Only. Responsible for identifying and securing business opportunities with cosmetic brands. Wellness enterprises.

The ideal candidate will have experience in graphic design with a focus on regulated environments and a strong understanding of pharma-specific packaging components such as labels, cartons, leaflets, and blister packs.

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch?v=tASq7Ld0JsQ About the Role: ValGenesis is the market leader in end-to-end digital validation and we are looking for a Lead Validation Engineer to join our team in Chennai. In this role you will drive the validation processes of our cutting-edge products, ensuring they meet the highest quality standards. Responsibilities Collaborating with Product, Engineering, and Testing teams to gain a comprehensive understanding of product functionalities. Reviewing Product Requirements including Epics, User Stories, and Software Requirements. Developing thorough test cases in Operational Qualification (OQ) and Performance Qualification (PQ) protocols aligned with guidelines. Creating realistic test cases and datasets based on real-world customer scenarios. Executing test cases, logging defects, documenting deviations, and reporting test outcomes. Peer reviewing test documentation to ensure quality and adherence to standards. Working collaboratively in a dynamic team environment with open communication. Understanding and adhering to Quality Management System (QMS) standards. Leading a team of engineers, providing guidance, overseeing workload, and conducting reviews. Managing product validation timelines and ensuring quality deliverables. Requirements Bachelor's or higher degree in Computer Science, Biology, Biomedical Engineering, or a related field. At least 8 years of experience in Computer System Validation and Product Software Validation in a regulated environment. Deep knowledge of the product development life cycle. Understanding of GMP, FDA, and ISO regulations. Proficiency with testing tools and Microsoft Office suite. Self-motivated with a willingness to quickly learn new technologies and products. Excellent interpersonal, writing, communication, and troubleshooting skills. Passionate about testing, validation, and product quality. Able to mentor colleagues and lead small projects efficiently. We’re on a Mission In 2005, we disrupted the life sciences industry by introducing the world’s first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard. Today, we continue to push the boundaries of innovation enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations. The Team You’ll Join Our customers’ success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity’s quality of life, and we honor that mission. We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done. We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward. We’re in it to win it. We’re on a path to becoming the number one intelligent validation platform in the market, and we won’t settle for anything less than being a market leader. How We Work Our Chennai, Hyderabad and Bangalore offices are onsite, 5 days per week. We believe that in-person interaction and collaboration fosters creativity, and a sense of community, and is critical to our future success as a company. ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by local law.

Hi We are hiring for Regulatory Submissions Publisher . Job Purpose: Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) QC submission dossiers or parts of submission dossier output of low-to-moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre-established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 369 b) For Position in Bangalore Search : Job Code # 370 c) For Position in Hyderabad Search : Job Code # 371

Key Responsibilities Quality Strategy & Planning Develop and implement quality control standards, procedures, and policies. Define inspection criteria and quality benchmarks. Team Management Lead and supervise a team of quality inspectors or analysts. Provide training and guidance to QC staff. Manage and supervise QC laboratory activities Use effective negotiation skills to drive alignment and resolve conflict Inspection & Testing Oversee routine inspections and testing of raw materials, in-process, and finished products. Ensure compliance with internal and external specifications and regulations. Documentation & Reporting Maintain detailed records of quality control activities. Analyze QC data and generate reports to identify trends and areas for improvement. Compliance & Audits Ensure compliance with ISO, GMP, or other industry-specific standards. Coordinate and support internal and external audits. Problem Solving Investigate product quality issues and customer complaints. Implement corrective and preventive actions (CAPA).

Skill required.. •Accomplish ITQM objectives in the assigned project by planning, executing and evaluating quality activities (as per service description). Accountable that assigned projects implement security and compliance with applicable laws/regulations like CSV, NVS Standards, the IMF, and project methodology Hands-on experience in Regulatory Compliance (UK DPA, SOX, PII, Data Privacy & Security etc.). Should be able to liaison with the client information security, compliance & legal teams on regulatory requirements & facilitate evidence provisioning during audits • Experience in implementation of at least 2 complete cycles of Information Security Management Systems. Good understanding of domains such as Network security, Firewall audits, VA/PT, Access Management etc. Should have experience in domains such as ISAE3402 • Strong knowledge of Qualification and Validation project development/implementation processes. • Excellent FDA GxP understanding. • Knowledge of SoX, cGMPs, FDA and EMA guidelines. • Preferred Certifications: ISO 27000 LA, CISA, CISM, CISSP, ISO 9000 • Experience in planning & conducting & leading internal audits on information security, pharma quality & compliance • Experience in audits of ITSM processes (Change Mgmt, Incident/Problem Mgmt). ITIL V3 foundation must. • Good Program/Project management skills along analytics & reporting skills with strong communication & presentation. • Ability to work with all level of clients & internal resources • Knowledgeable about Business Continuity Management & Disaster Recovery. ISO 22301 experience preferred. JD • Point of contact for client stakeholders as well as HCL Operations team for guidance & support regarding compliance control requirements and implementation into service operations • Create & Document the control compliance plans for all services in scope • Lead Compliance processes for large Pharmaceutical Client for specific geography • Manages the infrastructure Qualification of hardware/Servers. • Maintains categorization of Off-the-shelf validation categories. • Ensure that the operations run-books & SOPs are inline & map with Policies, Standards, and Guidelines relating to security, privacy, and confidentiality for the Client IT Environment. Development of Security plan & ensuring adherence for all security domains relevant for in-scope services • Develop & Plan internal audit calendar aligned to clients internal as well as external audit schedule • Execute Security audits as per the agreed upon plan with client stakeholders and work with operations teams for remediation of any gaps and non-compliances • Provide agreed upon and ad-hoc reports for audits & compliance operations. • Facilitate in-time evidence provisioning to client audit, risk & compliance teams at time of external audits • Conduct process audits for ITSM as per agreed upon process controls • Participate in client meetings and committees that investigate compliance needs and develop new and modified Policies, Standards, and Guidelines We are looking for functional consultants have extensive experience in GxP related policies & process definitions and enforcements.

Computer System Validation Role Currently, we are urgently looking for junior/ mid-senior Labs System CSV / Validation professional for an opportunity in our consulting organization. Desired Skills and Experience A CSV consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs. Experience of QA in a FDA regulated environment is preferred. At least 2 years of Computer System Validation or any validation experience required. Experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report). Experience in any other validations (cleaning, process, etc.), temperature mapping etc. would be a plus: Excellent communication skills. Ability to work as a team player in a consulting environment. Proficiency with MS Office tools. Documentation management Strong Project Management experience (preferred but not required)

About The Role : Job Title- Regulatory Filtering Analyst, NCT Location- Bangalore, India Role Description Deutsche Bank (DB) Group and its staff are committed to compliance with all applicable laws and official regulations in the respective jurisdictions. Restrictive measures under sanctions and embargoes are usually implemented by means of statutory regulations. The sanctions and embargoes program is aimed to ensure that DB Group and its staff fully comply with all sanctions and embargoes regulations in force in the respective jurisdiction. For this purpose, DB established a global organization with dedicated rights and responsibilities. DBs Sanctions & Embargoes Program has been implemented globally and throughout all business divisions via the Embargo Policy - DB Group and the Special Risk Country Policy DB Group. The Service Operations (Operations) Profession is responsible for the delivery, oversight and management of functional teams undertaking operational and transaction-based processes, working within agreed policies, procedures, Key Performance and Risk Indicators. Operations objectives include designing and implementing a robust control environment that allows and drives efficient and effective processing. The environment should ensure we meet regulatory requirements and can verify the completeness and accuracy of all transactions and operational processes. The objectives include operational assurance on the integrity of the books & records and deliver effective service to our clients. Operations develop and maintain effective relationships across client and partner groups. The RTB Reviewer are primarily responsible for the appropriate review, confirmation and decision-taking on stopped messages to confirm mismatches for release from the transaction filtering process in line with applicable Sanction regulations and the Banks policies and procedures. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Support the RTB team lead in protecting DB from legal, regulatory, and reputational risk regarding business involving sanctioned entities and / or countries. Perform quality assurance review in accordance with AML policies and departmental procedures within established timeframes. Perform timely Quality activities such as day to day quality reviews on alerts processed by RTB users. Update all relevant MI to confirm completion of reviews and errors identified. Execute internal control checks as defined in the KOP documentation and Embargo control framework documents governed by AFC Sanction & Embargo. Support any applicable reporting obligations to the competent authorities with respect to transaction handling. Provides insight into quality gaps discovered as part of the quality assurance process and ensures these gaps are communicated to appropriate management. Identify opportunities for improvement and drive the implementation of initiatives and process changes with a focus on innovation. Act as a process expert and extends support to the operations team by sharing best practices amongst quality and the operations teams. Should be proficient in excel handling including the use of Excel's functions, features, and formulas to organize, analyze, and adjust data. Understanding Excel proficiency involves knowing its various tools, formulas, and functions. Your Key Accountabilities RTB focus. Primarily review transactions handled by operations team and their decision on them (either pass or investigate), based on limited set of rules provided and maintained by AFC. Review the rationale for the decision from pre-defined set of options. Share feedback for investigators/reviewers with the operational leads and share trends in errors. Provide support feedback loop and filter optimization by identifying repeat mismatches to propose Good Guys. Use user access privileges only for authorized purposes; actively safeguard sensitive and confidential information. CTB focus. Perform quality assurance on TSMO / AFC related change projects. Perform quality assurance on the parameter settings in the screening application and quality review of good guys approved and add to ensure the rules are adhered to. Training & Development Participate Trainings such as on HotScan, Sanctions policies, L1 procedures, specific payment types, including structure / form of messages. Your skills and experience Sanctions and Regulatory Filtering SWIFT Message Format and Fields SWIFT Payment Flow SEPA Message Structure and Payment Flow ISO 20022 MS Office (MS Excel, Word and Outlook) Proficient in e mail communication Good communication skills (Written & Verbal) Ability to support rotational shifts Ready to support on weekends How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

Ensure contractor compliance with GMP and regulatory standards.Conduct audits and inspections of contractors, manufacturers, and suppliers.Review and approve Batch Records, SOPs, and quality documents. Required Candidate profile Manage deviations, CAPA, and ensure timely corrective actions. Liaise between contractors and internal teams for smooth operations.

Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.). QC submission dossiers or parts of submission dossier output of low-to- moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission- ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; and Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre- established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties Problem solving skills Management of team Knowledge of business principles. Key Skills: a) Grad or PG in Nursing, Pharmacy or Life Sciences b) 2or more years of experience in pharmaceutical industry submission publishing or related technical skills c) Familiarity with FDA or EU regulations & guidelines To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Noida Search : Copy and Paste the link below https://outpace.in/job/regulatory-submissions-publisher-4/

Manage the technology transfer process for established products, ensuring robust and compliant manufacturing processes e.g. implementation of new API sources. Write, review, and maintain regulatory response documents, justification reports, and risk assessments related to technology transfer activities. Oversee the preparation and review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for smooth transfer and manufacturing. Review process validation protocols and reports. Coordinate with R&D, production, quality assurance, and regulatory teams to ensure alignment on project deliverables and timelines. Troubleshoot and optimize manufacturing processes addressing deviations and improving efficiency. Conduct technical risk assessments to identify and mitigate potential issues during and post-transfer. Maintain comprehensive documentation to ensure compliance with regulatory standards (e.g., FDA, EMA, cGMP) and internal quality guidelines. Stay updated on regulatory trends and industry standards to continuously improve documentation practices and technology transfer methodologies.

About Janitri Janitri is a Med-tech company that develops IoT-based smart pregnancy and newborn monitoring devices. Apart from a recent feature in Shark Tank, Janitri has won numerous awards and accolades for its life-saving innovations. About the position: We are seeking a highly motivated and experienced Senior Regulatory and Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the product lifecycle of Class II medical devices. This role requires a deep understanding of regulatory affairs, quality management systems, and strong attention to detail. Roles and Responsibilities: Regulatory Compliance: Lead regulatory submissions (510(k), Technical Files, Design Dossiers) for Class II medical devices to regulatory authorities (FDA, Notified Bodies, etc.). Interpret and apply regulations (FDA QSR, ISO 13485, MDR, etc.) to ensure compliance of products and processes. Monitor changes in regulations and communicate potential impacts to relevant stakeholders. Quality Management Systems: Develop, implement, and maintain quality management systems (QMS) to ensure compliance with regulatory requirements and industry standards. Conduct internal audits and oversee external audits to assess QMS effectiveness and identify areas for improvement. Manage corrective and preventive action (CAPA) processes to address quality issues and prevent recurrence. Product Lifecycle Management: Provide regulatory guidance and support to cross-functional teams throughout the product life cycle, from product development to post-market surveillance. Review and approve design control documentation, including design inputs, verification/validation plans, and risk management activities. Support regulatory assessments of product changes and design modifications. Compliance Documentation: Prepare and maintain regulatory documentation, including regulatory submissions, technical documentation, and quality records. Ensure documentation is accurate, complete, and in compliance with applicable regulations and standards. Required Skills: Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred. Minimum of 10+ years of experience in regulatory affairs and quality assurance within the medical device industry, with specific experience in Class II devices. In-depth knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards. Experience with regulatory submissions, including 510(k) applications and Technical Files. Strong analytical skills and attention to detail. Excellent written and verbal communication skills. Ability to work effectively in a cross-functional team environment.