679 Fda Jobs - Page 13

Job Responsibilities Operations Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning. Provide management and leadership direction for the development and implementation of quality and compliance programs. Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices. Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents. Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to clien...

Job Description: FDA Manager Food/FMCG (15-20 yrs) Position: FDA Manager Department: International Business Timings: 12:00 Pm to 9:00 pm We are looking for a seasoned US FDA Clearance Manager with 1520 years of experience in Regulatory Affairs & Compliance for Food/FMCG, with a strong focus on the US market. Key Responsibilities: Lead all USFDA clearance, approvals & compliance processes. Ensure adherence to 21 CFR, FSMA, FSVP, labelling & packaging norms . Manage dossiers, regulatory submissions & audit inspections. Guide cross-functional teams (R&D, QA, Production, Exports). Liaise with USFDA, certification bodies, distributors & consultants. Qualification & Experience Degree in Food Tech/...

Role & responsibilities Minimum of 10 years of Life Science industry experience, with substantial exposure to regulatory affairs. Hands on experience and demonstrated expertise in Chemistry, Manufacturing, and labeling processing Comprehensive understanding of global regulatory framework, including FDA, EMA, ICH and other international standards. Excellent communication skills both written and verbal Meticulous attention to detail and organizational prowess Proficiency in project management and cross-functional collaboration Strong analytical and problem-solving skills Ability to navigate and interpret complex regulatory landscapes across multiple regions Good understanding of Quality Manage...

Work Flexibility: Hybrid What will you do : Collaborate with cross-functional teams (Engineering, Quality, Regulatory, Supply Chain, Manufacturing) to execute product transfers. Responsible for process development and all process documentation (SOPs, Work Instructions, BOMs, Routers, PFMEAs, Control Plans) is reviewed, updated, and transferred Prepare and review PPAP documents (PFMEA, Control Plans, Process Flow Maps, , Process Capability Study, inspection plans etc) and support method qualifications Develop and qualify gages: perform Gage R&R and MSA studies Review and qualify manufacturing processes, ensuring regulatory and quality compliance Coordinate with supplier quality and sourcing t...

Job Responsibilities Operations Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning. Provide management and leadership direction for the development and implementation of quality and compliance programs. Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices. Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents. Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to clien...

Job Description Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand and Canada market and Customers. Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required. To provide Regulatory inputs during product development, manufacturing and testing and to evaluate all types of change proposals during product life cycle Work Experiance Should have worked in Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US etc (minimum 1-2 years). Submission of new submissions, deficienc...

The team focusing on Healthy Aging through AI is looking for a talented individual to join their 2019 X-ray AI project under the Global Business Team. The team, led by the CEO, is at the forefront of innovation in healthcare technology, aiming to revolutionize the industry through cutting-edge AI solutions. As a member of this team, your main tasks will include collaborating with Key Opinion Leaders (KOL) to drive the project's success. You will be responsible for setting and achieving key performance indicators (KPI) related to Regulatory Affairs/Quality Assurance (RA/QA), Research and Development (R&D), and more. The ideal candidate for this role should be an Osteo Signal Global Game Chang...

The ideal candidate will be responsible for providing care to patients while adhering to compliance standards. You should be able to recognize patient needs and prioritize those needs with the needs outlined by physicians. You will be responsible for assuring quality care by adhering to standards set by the physicians. Additionally, you will provide care education to patients in person or over the phone and adhere to compliance guidelines throughout processes (OSHA, FDA, HIPAA). To qualify for this position, you must be a Registered Professional Nurse with current licensure. It is also required to have CPR, ACLS, and BCLS Certification. Knowledge of OSHA, FDA, and HIPAA compliance is essenti...

Exp. in Biopharmaceuticals Biosimilars consulting and strategy oriented projects Strong foundation in pharmaceutical and drug dev. lifecycle understanding of commercialization process, or Biopharmaceuticals o Excellent communication skills

Warm Greetings from SP Staffing!! Role: JDEdwards Consultant Experience Required :1 to 6 yrs Work Location :Pan India Required Skills : CNC Admin Interested candidates can send resumes to nandhini.s@spstaffing.in

Warm Greetings from SP Staffing!! Role: JDEdwards Consultant Experience Required :3 to 8 yrs Work Location :Pune/Mumbai/Hyderabad Required Skills : JDE Technical Interested candidates can send resumes to nandhini.s@spstaffing.in

Position Summary: We are looking for an experienced R&D Engineer Trainer with 1015+ years of expertise in the medical device industry . This role will focus on leading training programs in the design , development , and optimization of innovative medical technologies . The trainer will provide guidance on the full new product development (NPD) lifecycle from concept through commercialization while ensuring alignment with global regulatory requirements. The position also involves close cross-functional collaboration to support the delivery of safe, effective, and high-quality medical devices that enhance patient outcomes. Key Responsibilities: Lead the design and development of new medical de...

Responsibilities: * Exp on procedure of application of new Drug * Manage COPPs, GMP, GLP compliance & SUGAM portal maintenance * Oversee license renewals, dossier reviews & NIB submissions * Trademark License & Coordinate with Drug Control Authority

Experience in verification, validation, or testing complex systems. Specifically, modules which controls Sensors, Actuators, Power Supplies.. etc Knowledge of V-model, FDA 21 CFR Part 820, IEC 60601 and collateral standards.

Role - Sr. Data Scientist Experience - 5+ Years Duration - 6 months contract (either extension or internalisation after that) Location - Bangalore (Hybrid) Start - Within two weeks Required Qualifications: PhD or masters degree in computer science, Biomedical Engineering, Applied Mathematics, or a related field. • 5+ years of experience in data science or machine learning, with at least 3 years focused on medical imaging. • Strong experience in deep learning frameworks (TensorFlow, PyTorch) and model architectures for computer vision. • Practical exposure to foundation models, including prompt engineering, fine-tuning, and domain adaptation. • Proven ability to work with 2D/3D imaging datase...

position: Contract to Hire(C2H) Skill: IT Configuration Engineer Experience:6+ Location: Pan India Notice Period: Immediate to 15 Days Job Descrption: Description During the implementation of the new MES environments, the IT configuration engineer is the local resource assisting in setting up the interfaces to MES, performing the system configurations and writing & reviewing validation documentation and executing test cases. Profile: - MES knowledge (PAS-X certification) MES project experience & setting up IT infrastructure & system configuration for this - Familiar with life sciences manufacturing processes & standards (inc. GMP practices) Candidates who are Interested for above Position , ...

Role & responsibilities The Regulatory Affairs (RA) & Global Registration Executive/Manager will be responsible for managing end-to-end global regulatory submissions, maintaining compliance with regional and international regulatory requirements, and facilitating timely registration and market access for medical devices across multiple geographies. Prepare and submit dossiers (510k, CE, CDSCO, etc.) as per country-specific regulations. - Maintain registration records and handle renewal processes. Monitor global regulatory updates and assess product impact. - Coordinate with QA, R&D, and marketing for data collection and documentation. - Respond to regulatory queries and deficiency letters. S...

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization. Key Responsibilities: Prepared, reviewed...

Job Description: Job Title: Regulatory Filtering Analyst Corporate Title: NCT Location: Bangalore, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require go...

Required Skills and Qualifications: Collect and maintain hashtag#structureddata from global hashtag#regulatoryauthorities (e.g., hashtag#EMA , hashtag#FDA , hashtag#TGA ), hashtag#HTA agencies (e.g., hashtag#NICE , hashtag#HAS , hashtag#CADTH ) and pricing bodies (e.g., hashtag#DMD , hashtag#CODAGE , hashtag#PBS ) • Masters degree in hashtag#pharmacy . • Strong interest or foundational knowledge in hashtag#pharmaceuticaldrug development, hashtag#regulatory affairs, or hashtag#clinical trials. • Excellent attention to detail and ability to work with hashtag#structured data sets . • Proficiency in using hashtag#MS Excel , hashtag#Word , and hashtag#basic data tools.

Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Preparing and submitting regulatory applications such as permits, licenses, certific...

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 th...

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 th...

Job Title: Junior Auditor - Quality Assurance (QA) Department Job Summary: The Junior Auditor in the QA Department assists in performing internal quality audits to ensure compliance with company policies, industry standards (e.g., ISO, GMP, FDA), and regulatory requirements. This role involves document review, data analysis, audit preparation, reporting, and follow-up on corrective and preventive actions (CAPAs). Key Responsibilities: Audit Support & Execution: Assist in planning and conducting internal audits for various departments to verify compliance with quality standards. Participate in process and system audits under the guidance of senior auditors or QA managers. Support the audit li...

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Job Description We are looking for a skilled & driven Product Owner with a strong technical background and experience in the healthcare domain. The ideal candidate will lead the product /platform development efforts, ensuring ...