Senior Regulatory Affairs Trainer(Medical Devices)

Job Title: Senior Trainer – Regulatory Affairs (Medical Devices)

Location: Remote

Job Type: Part-Time

Job Summary:

Regulatory Affairs Trainer

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.