Staff Engineer - Global Regulatory

Work Flexibility: Hybrid

What you will do :

• Develop and execute regulatory strategies for product approvals in global markets (e. g. , FDA, EU MDR, Health Canada, TGA, China NMPA, Japan PMDA).
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR 2017/745, and other international regulatory frameworks.
• Provide strategic regulatory input during product development, clinical evaluations, and post-market surveillance.
• Conduct regulatory risk assessments and advise leadership on global compliance requirements.
• Lead the preparation, submission, and approval of complex regulatory filings, including 510(k), CE Marking (Technical Files), and international registrations.
• Oversee labeling compliance, ensuring all claims meet regulatory requirements.
• Manage regulatory lifecycle activities, including change notifications, renewals, and market expansions.
• Oversee post-market regulatory requirements, including adverse event reporting, vigilance submissions, and field actions.
• Collaborate with R&D, Quality, Clinical, and Commercial teams to ensure regulatory alignment throughout the product lifecycle.
• Provide regulatory support for FDA inspections, ISO audits, Notified Body reviews, and internal audits.
• Mentor and train junior regulatory staff, sharing expertise and best practices.
• Monitor and interpret regulatory trends and policy changes, ensuring the company remains proactive in compliance.

What you will need :

• Education: Bachelor s or Master s degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field.
• Experience: 8+ years of regulatory affairs experience in the medical device industry.
• Expert knowledge of EU MDR, FDA regulations, ISO 13485, MDSAP, and other global regulatory requirements.
• Proven experience leading 510(k), PMA, CE Marking, and international regulatory submissions.
• Strong problem-solving and leadership skills, with experience in cross-functional collaboration.
• Ability to work independently while managing multiple complex projects.
• Regulatory Affairs Certification (RAC) or equivalent is a plus.

Travel Percentage: 10%