Senior Regulatory Affairs Trainer(Medical Devices)

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.