About this opportunity
Mondo lists this Market Regulatory Affairs Manager opportunity in bedford, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
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Worksite address
bedford, MA, 01730, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.