Senior Regulatory Affairs Trainer(Medical Devices)

1 day ago

Noida, India Tek Support Full time

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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