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1 week ago Be among the first 25 applicants This range is provided by Mondo. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $180,000.00/yr - $200,000.00/yr Position Overview: We are seeking a seasoned Market Regulatory Affairs Manager to lead and evolve our post-market regulatory affairs team supporting hemostasis and acute care diagnostic products, including GEM product lines. This is a high-impact, high-visibility leadership role responsible for overseeing global post-market regulatory activities, including adverse event reporting, recalls, and compliance with international market requirements. The successful candidate will bring both strategic vision and hands-on expertise, with a proven ability to drive best-in-class regulatory processes in a high-volume IVD or medical device environment . You will lead a team of five experienced professionals and be expected to foster a respectful, collaborative, and improvement-driven culture while bringing clear, confident leadership to cross-functional discussions and regulatory engagements. Key Responsibilities: Lead and mentor a team of 5 regulatory affairs professionals focused on global post-market support Oversee and improve post-market surveillance systems in accordance with EU IVDR and other international regulations (FDA, MDSAP, etc.) Manage global adverse event reporting , ensuring timely and accurate submissions to authorities in key markets (EU, North America, Brazil, Japan, Canada, Mexico) Guide regulatory determinations for design and labeling changes impacting on-market products Coordinate and manage recall activities , working closely with Quality and Compliance teams Serve as a strategic partner to internal stakeholders, ensuring regulatory risk is communicated clearly and proactively Develop and implement process improvements to support compliance and operational excellence across all regions Act as a strong, credible voice for the regulatory team in high-level discussions and crisis management situations Ensure consistent global compliance across 100+ IVD technical files and support up to 50–100 regulatory activities monthly Qualifications: 7+ years of people management experience within regulatory affairs, preferably leading seasoned professionals Strong working knowledge of post-market regulatory requirements , including international adverse event reporting (EU and North America required) Experience with IVDR , recall management , and regulatory assessments of labeling and design changes Demonstrated experience working in a high-volume company (e.g., Abbott, Siemens, Roche, or similar) Deep understanding of regulatory timelines, urgency, and global market dynamics Collaborative leadership style with ability to build trust , assess team strengths , and implement process improvements without disrupting team cohesion Practical, solutions-focused mindset and the confidence to represent the team in high-stakes situations Preferred Qualifications: Experience in IVD (In Vitro Diagnostics) highly preferred Familiarity with MDSAP regulations and affiliate communications Experience working cross-functionally with global affiliates and regulatory authorities Prior success implementing regulatory best practices in a transitioning or evolving team environment Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Engineering and Product Management Industries Staffing and Recruiting Referrals increase your chances of interviewing at Mondo by 2x Sign in to set job alerts for “Regulatory Affairs Manager” roles. Sr Regulatory Affairs Specialist--Remote Senior Manager, Regulatory Affairs, Operations Boston, MA $120,000.00-$125,000.00 2 weeks ago Regulatory Affairs CMC Specialist - Contract Westford, MA $97,300.00-$194,700.00 2 months ago Senior Regulatory Affairs Specialist / Regulatory Affairs Manager (994) Senior Regulatory Affairs Specialist / Regulatory Affairs Manager Senior Manager, Regulatory Affairs Device Associate Director, Global Regulatory Affairs Associate Director, Regulatory Affairs CMC Manager, Global Regulatory Affairs, Marketed Products Boston, MA $111,800.00-$175,670.00 3 weeks ago Senior Manager, Regulatory Affairs (Clinical) Boston, MA $130,000.00-$180,000.00 2 days ago Manager, External and Regulatory Affairs We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr