Regulatory Manager

Role & responsibilities

• Lead regulatory strategy and submissions for the US FDA, Health Canada, EU MDR, UKCA/MHRA, TGA Australia, China NMPA, Brazil, and other global markets.
• Must have a proven track record of successfully handling 510(k), ARTG, Health Canada, and EU MDR submissions.
• Maintain applicable government and regulatory portals, including CDRH, FDA FURL, GUDID, MDUFA, EUDAMED, and other relevant systems.
• Manage registrations, approvals, renewals, and lifecycle compliance for medical devices and IVDs.
• Develop regulatory pathways, including device classification, applicable FDA regulations, product codes, and regulatory strategies, and plan product launches in MDSAP-member countries.
• Coordinate with regulatory authorities, notified bodies, testing laboratories, and certification agencies.
• Manage regulatory reporting to MDSAP-member countries and EU authorities, as applicable, in the event of adverse events or other reportable incidents occurring in the market.
• Prepare and maintain Technical Documentation/Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs), Risk Management Files, UDI documentation, and other regulatory documentation.
• Support global product launches and market expansion into regulated markets.
• Must have experience with US FDA inspections, including handling Form 483 observations.
• Manage and respond to regulatory queries raised by MDSAP authorities and other regulatory authorities in applicable markets.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR 2017/745, applicable IEC standards, and other international regulatory requirements.
• Provide regulatory guidance and support to R&D, Quality, Manufacturing, and Executive Management teams.

Preferred candidate profile

• Bachelor's or Master's degree in Biomedical Engineering, Biotechnology, Pharmacy, Life Sciences, Regulatory Affairs, or related discipline
• 8+ years of Medical Device Regulatory Affairs experience
• Strong expertise in FDA, EU MDR, Health Canada, TGA, MHRA, and NMPA regulations
• Proven success in obtaining international regulatory approvals
• Excellent leadership, stakeholder management, and communication skills

Preferred:

• Experience managing multi-country registrations simultaneously
• Knowledge of Software as a Medical Device (SAMD or SIMD) and Active medical devices
• Experience with CE Marking and Post-Market Surveillance.

What We Offer:

• Leadership role with global exposure

• Opportunity to work on innovative medical device technologies

• Growth-oriented and collaborative environment

• Competitive compensation package