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%