Senior Regulatory Affairs Trainer(Medical Devices)
3 hours ago
Job Title: Senior Trainer – Regulatory Affairs (Medical Devices) Location: Remote Job Type: Part-Time Job Summary: We are seeking an experienced Regulatory Affairs Trainer with deep expertise in medical device regulations and compliance to design and deliver advanced training programs for professionals in the medical device industry. The ideal candidate will have hands-on experience in global regulatory submissions, product registration, quality system compliance, and post-market surveillance. Key Responsibilities: Develop and deliver training modules on global regulatory frameworks including US FDA (21 CFR 820, 803, 806), EU MDR 2017/745, ISO 13485:2016 , and other international standards. Train teams on regulatory documentation, technical files, design dossiers, and CE marking processes. Conduct workshops on device classification, risk management (ISO 14971), clinical evaluation (MDR Annex XIV), and labeling requirements . Provide practical case studies and hands-on sessions on submission preparation for FDA 510(k), PMA, and global market approvals. Mentor regulatory teams on change management, post-market surveillance, vigilance reporting , and regulatory strategy. Collaborate with QA/RA and R&D teams to align training content with current regulatory updates and audits findings . Assess training effectiveness and continuously improve course content to ensure compliance and up-to-date practices. Support organizations during regulatory inspections and internal audits by enhancing team competency. Required Qualifications & Experience: Bachelor’s or Master’s degree in Biomedical Engineering, Pharmacy, Life Sciences, or related field . Minimum 10 years of experience in Regulatory Affairs within the medical device industry . Strong knowledge of global regulatory systems (US, EU, Canada, India, Japan, etc.). Proven track record in regulatory submissions, audits, and compliance management . Experience in training, mentoring, or developing learning content for regulatory professionals. Excellent communication, presentation, and documentation skills. Preferred Skills: Certification in Regulatory Affairs (e.g., RAC from RAPS) or equivalent. Knowledge of combination products, IVDs, and software as a medical device (SaMD) . Exposure to Notified Body audits and third-party inspections . Experience using LMS (Learning Management Systems) or e-learning tools for content delivery.
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Senior Regulatory Affairs Trainer(Medical Devices)
10 hours ago
Noida, India Tek Support Full timeJob Title: Senior Trainer – Regulatory Affairs (Medical Devices)Location: RemoteJob Type: Part-TimeJob Summary:We are seeking an experienced Regulatory Affairs Trainer with deep expertise in medical device regulations and compliance to design and deliver advanced training programs for professionals in the medical device industry. The ideal candidate will...
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Senior Regulatory Affairs Trainer(Medical Devices)
23 hours ago
Noida, India Tek Support Full timeJob Title: Senior Trainer – Regulatory Affairs (Medical Devices)Location: RemoteJob Type: Part-TimeJob Summary:We are seeking an experienced Regulatory Affairs Trainer with deep expertise in medical device regulations and compliance to design and deliver advanced training programs for professionals in the medical device industry. The ideal candidate will...
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Senior Regulatory Affairs Trainer(Medical Devices)
22 hours ago
Noida, India Tek Support Full timeJob Title: Senior Trainer – Regulatory Affairs (Medical Devices) Location: Remote Job Type: Part-Time Job Summary: We are seeking an experienced Regulatory Affairs Trainer with deep expertise in medical device regulations and compliance to design and deliver advanced training programs for professionals in the medical device industry. The ideal candidate...
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Noida, India Tek Support Full timeJob Title: Senior Trainer – Regulatory Affairs (Medical Devices)Location: RemoteJob Type: Part-TimeJob Summary:We are seeking an experienced Regulatory Affairs Trainer with deep expertise in medical device regulations and compliance to design and deliver advanced training programs for professionals in the medical device industry. The ideal candidate will...
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Noida, India Tek Support Full timeJob Title: Senior Trainer – Regulatory Affairs (Medical Devices)Location: RemoteJob Type: Part-TimeJob Summary:We are seeking an experienced Regulatory Affairs Trainer with deep expertise in medical device regulations and compliance to design and deliver advanced training programs for professionals in the medical device industry. The ideal candidate will...
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Noida, India Tek Support Full timeJob Title: Senior Trainer – Regulatory Affairs (Medical Devices) Location: Remote Job Type: Part-Time Job Summary: We are seeking an experienced Regulatory Affairs Trainer with deep expertise in medical device regulations and compliance to design and deliver advanced training programs for professionals in the medical device industry. The ideal candidate...
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Regulatory Affairs Executive
24 hours ago
Noida, Uttar Pradesh, India SR Strategy Services Full time ₹ 3,00,000 - ₹ 6,00,000 per yearRegulatory Executive (Medical Devices & IVDs)Experience:1–3 years inregulatory affairs for medical devices and/or IVDs under Indian MDR 2017Location:Noida (On-site)CTC :INR 3-6 LPAAbout SR Strategy Services LLP:SR Strategy Services LLP is a leading consulting firm specializing in strategic government affairs, regulatory advisory, market access solutions,...
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Regulatory Executive Medical Devices
24 hours ago
Noida, Uttar Pradesh, India SR Strategy Services Llp Full time ₹ 15,00,000 - ₹ 25,00,000 per yearRole & responsibilitiesPrepare, compile, and assist in submission of regulatory applications/dossiers for medical devices and IVDs under MDR 2017.Support licensing/registration processes (Forms MD-5, MD-14, MD-15, MD-16, MD-24 etc.) for multiple products and clients.Liaise with CDSCO, State Licensing Authorities, and notified bodies during submission and...
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Regulatory Affairs
5 days ago
Noida, Uttar Pradesh, India corpseed ites pvt ltd Full time**Job Position**: Regulatory Compliance - Technical Role (CDSCO) **Experience Required**: 1 to 3year **Department**: Regulatory Affairs / Compliance - CDSCO Registration for medical devices, Drug & Cosmetics as per the rules and standards. - Draft, review, submission and archival of other regulatory submissions (Query responses, corrections fillings,...
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Regulatory Affairs Specialist
1 week ago
Noida, Uttar Pradesh, India Gentell Full time ₹ 15,00,000 - ₹ 28,00,000 per yearGentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life.Our success is a result of the...
