Senior Regulatory Affairs Trainer(Medical Devices)

Job Title: Senior Trainer – Regulatory Affairs (Medical Devices)Location: Remote Job Type: Part-TimeJob Summary: We are seeking an experiencedRegulatory Affairs Trainerwith deep expertise inmedical device regulations and complianceto 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 delivertraining moduleson global regulatory frameworks includingUS FDA (21 CFR 820, 803, 806), EU MDR 2017/745, ISO 13485:2016, and other international standards. Train teams onregulatory documentation, technical files, design dossiers, and CE markingprocesses. Conduct workshops ondevice classification, risk management (ISO 14971), clinical evaluation (MDR Annex XIV), and labeling requirements. Provide practical case studies and hands-on sessions onsubmission preparationfor FDA 510(k), PMA, and global market approvals. Mentor regulatory teams onchange management, post-market surveillance, vigilance reporting, and regulatory strategy. Collaborate with QA/RA and R&D teams to align training content withcurrent regulatory updates and audits findings. Assess training effectiveness and continuously improve course content to ensure compliance and up-to-date practices. Support organizations duringregulatory inspections and internal auditsby enhancing team competency.Required Qualifications & Experience: Bachelor’s or Master’s degreeinBiomedical Engineering, Pharmacy, Life Sciences, or related field. Minimum 10 years of experiencein Regulatory Affairs within themedical device industry. Strong knowledge ofglobal regulatory systems(US, EU, Canada, India, Japan, etc.). Proven track record inregulatory submissions, audits, and compliance management. Experience intraining, mentoring, or developing learning contentfor regulatory professionals. Excellent communication, presentation, and documentation skills.Preferred Skills: Certification inRegulatory Affairs (e.g., RAC from RAPS)or equivalent. Knowledge ofcombination products, IVDs, and software as a medical device (SaMD). Exposure toNotified Body audits and third-party inspections. Experience usingLMS (Learning Management Systems)or e-learning tools for content delivery.

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