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