679 Fda Jobs - Page 24

Continuously update knowledge of relevant regulations, guidelines, and industry standards. Ensure that products and processes adhere to all applicable regulations throughout the lifecycle, from development to post-market surveillanc Required Candidate profile Prepare, review, and submit regulatory documentation, including applications, reports, and amendments, to regulatory agencies. Prepare for and participate in regulatory audits.

Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quali...

Urgent : Assistant Manager / Manager {Regulatory & Food Safety} @ Shirwal , Near Pune / Satara Our client is leading Ice Cream Manufacturer of India , UAE & UK They are a professionally managed global conglomerate with traditional values of the 70-year-old family business. They directly employ over 2000 people across several regions of operations & includes the ownership & management of the boutique hotel in Mumbai, Banquets & Catering services, Indias largest ice-cream store chain , extremely delicious lower-calorie ice cream brand , the leading ice cream & food brand of the Middle East offering traditional Indian packaged foods such as paneer, frozen vegetables, rice & more a chain of mode...

Review SOP Support quality system Familiar with process/cleaning validation Assist internal & external audits Assist specification settings, OOS investigation, change controls, regulatory submission/update, annual product reviews, other investigation Required Candidate profile Must have min. 2 yrs experience & must be familiar with cGMP requirements. Candidate should have good knowledge of computer & ability to effectively interact with individuals at all levels.

Work collaboratively with regulatory, quality, package engineering, document control, and product development team(s) to develop new product labelling (Label/IFU/User documentations) Understanding country specific regulatory needs Labelling design as per regulatory & business requirements Review of all labelling based on the various domestic and international requirements – including product labels, instructions for use, e-labelling, website, advertising, and promotional materials Understands impact(s) of labelling design and development as part of overall product and packaging development. Effectively engages with the project team and seeks out support when appropriate. Manages change contr...

Job Title: Quality and Regulatory Manager (Medical Devices) Reports to: Director of Quality / Head of Operations Job Summary The Quality and Regulatory Manager is responsible for ensuring that all medical device products comply with global regulatory requirements (e.g., US FDA, EU MDR, ISO 13485), maintaining effective quality management systems, and facilitating successful regulatory submissions. The role involves leading internal and external audits, managing documentation, and supporting cross-functional teams to ensure the safety, efficacy, and compliance of medical devices throughout the product lifecycle. Key Responsibilities Quality Management System (QMS): Develop, implement, and mai...

Job Title: Senior Regulatory Publishing Specialist Responsibilities:Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets.eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch.Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time subm...

Define product positioning, pricing, and promotion strategies in collaboration with marketing teams. Develop product roadmaps aligned with company goals and market demands.Monitor product performance post-launch and recommend adjustments as needed

Role & responsibilities Manage timely delivery of feed tank to HCM with compliance to IPQC parameters and supervises all resources (raw material, equipment, manpower) and activities in a shift. This will be in-line with the schedule prepared by the In-charge for that day. Execute the shift activities (MM Charging, review FT planning, shift manpower deployment) allocated to him as per the plan Ensure shift handover/takeover on the shop floor and hold accountability for any failures/challenges in the previous shift. Review the dipping schedule daily to prioritize the FT preparation schedule, color change, ZMICs for specific requirements for all upcoming batches and highlight the necessary corr...

Manager Data Management,FSP(MDM,FSP) is responsible to support the Sr.Manager, Data management FSP in providing leadership, direction, and operational management operation. MDM FSP is responsible for line managing, developing CDM team withing the FSP

QMS Implementation Audit facilitation: will represent the company during regulatory/ 3rd party audits: MHRA, USFDA, MCC, WHO, etc. Products: temperature-controlled packaging & temperature monitoring systems used for storage & transit of medicines Required Candidate profile Any science graduates 10-15 years' experience in quality, ideally in pharma/ medical devices/ equipment manufacturing industry International Audit Experience mandatory Should be open for global travel

Job Description Candidate shall manage projects from concept to commercialization, ensuring projects stay on time, within budget, and meet regulatory requirements. • Develop project plans, manage resources, monitor progress, and handle changes to achieve project goals, while also ensuring compliance with relevant regulations, like FDA and EU guidelines • Communicate effectively with stakeholders, including clients, management, and internal Cross-functional teams Roles & Responsibility Demonstrated proficiency in the following areas: • Strong understanding of product development lifecycle, design controls, and regulatory requirements. • Experience in managing medical device development projec...

The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Sr Associate include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting an...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more ...

IVL India Environmental RD is looking for Quality Expert to join our dynamic team and embark on a rewarding career journey. Develop and implement quality assurance policies and procedures. Conduct quality audits and inspections. Analyze data to identify areas for improvement. Provide training on quality standards and processes. Ensure compliance with regulatory requirements.

Quality Control Dept, ensuring Timely testing & quality check of Raw Materials and Finished Products. Analysis on equipment like HPLC, FTIR, GC etc, all other Q.C. related matters Required Candidate profile Experience in handling HPLC, FTIR, GC etc, for 3 to 7 yrs, Experience in Quality Control dept. of Pharma Company. FDA Approval Required. Perks and benefits Apply with Salary Drawn & Expected Salary

Role & responsibilities QA Documents Preparation, review, & revision (such as Work Instructions, Flowcharts, SOPs, Inward Quality Plan, Technical Data Sheet, Formats, etc.) Document Control (Soft copy & Hard copy) Coordinate with QC, Production, Design team & management. Maintain master copy & distribute control copy of documents to respective departments. Gain knowledge regarding medical device applications. Developing and implementing quality systems: Including policies, procedures, and guidelines, to ensure that products or services meet the required quality standards. Conducting audits and monitoring processes to ensure that they comply with quality systems and standards. Handling Custom...

Key Responsibilities: Manage pharmacy operations, staff, and inventory. Ensure CDSCO, PCI, and NABH compliance. Optimize medication therapy for pediatric and maternity patients. Drive budgets and tech-driven efficiency. Collaborate with doctors and nurses for patient care. Requirements: B.Pharm/PharmD with 8+ yrs hospital exp. (5+ yrs leadership). Maharashtra Pharmacy Council registration. Expertise in clinical pharmacy, GMP, and regulations. Strong leadership & communication skills.

Experienced in pharmaceutical RA labeling, cGMP/FDA/CFR compliance, SPL creation, proofreading, and DSCSA. Skilled in MS Office, Adobe, TrackWise, SharePoint, and graphic design. Knowledge of label lifecycle, drug listing, and patent carve-outs.

Lead the design and development of innovative digital health products Oversee product lifecycle management from ideation to commercialization Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions Strong project management and UX design skills are required Knowledge of FDA and HIPAA regulations is a plus

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.

Responsibilities : Verification and Validation: Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, a...

We are looking for an experienced Senior Implementation Specialist with deep expertise in the life sciences industry to lead and execute complex implementations of our technology solutions. This role requires a seasoned professional with over 10 years of implementation experience, strong technical knowledge, and a proven track record in the life sciences domain. The ideal candidate will ensure seamless deployment, integration, and optimization of Freya Fusion, managing both client expectations and regulatory requirements. Key Responsibilities: Project Leadership : Lead the end-to-end implementation of Freya Fusion, overseeing all phases from project scoping and requirements gathering to conf...

Chemical Testing: Perform chemical test like FTIR, NMR, GC-MS, and titration to analyze the chemical composition of polymer Data Analysis, Sample Preparation Knowledge of statistical analysis technique quality management system, such as ISO 9001 Required Candidate profile Bachelor’s degree in chemistry, Polymer Science, Chemical Engineering Strong understanding of polymer chemistry and materials science We have 2 vacancies – 1 Male & 1 Female candidate.