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Tier-1 employer and metro location increase competition, though seniority and niche regulatory focus reduce density.
Medical-device PSUR, EU MDR, and risk management expertise are highly industry-specific and not easily transferable.
Explicit 8–12 years requirement plus mandatory PSUR/EU MDR and risk management skills make filters strict.
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Prepare and compile product post-market data into Periodic Safety Update Reports (PSURs) complying with regulatory requirements.
Mentor junior engineers and provide guidance on quality engineering practices related to medical devices.
Collaborate with cross-functional teams including regulatory affairs and medical experts to ensure accurate and timely PSUR submissions and compliance with safety regulations.
Bachelor's degree in Engineering (BE/BTech).
8 to 12 years of experience with Risk Management and Post-market quality experience, including PSUR preparation.
Experience in clinical medical writing, signal evaluations, and hands-on knowledge of EU MDR regulations.
Strong communication skills.
Experienced in cross-functional collaboration with regulatory and engineering teams in medical device quality and safety.
Capable of independent review ensuring compliance with development processes and regulatory standards.
Able to develop templates and training materials for quality system regulations and standards, and deliver presentations or training sessions.