Director/Senior Director of Regulatory Affairs

Director/Senior Director of Regulatory Affairs

Director/Senior Director of Regulatory Affairs

Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Barrington James Senior Recruitment Consultant - CMC & Regulatory Affairs

Director/Senior Director of Regulatory Affairs - Med Dev I’m partnering with an innovative, fast-scaling medical device company committed to transforming cardiovascular care through science-led solutions. With a mission rooted in improving patient outcomes, this company is pioneering a novel class technologies that emulate the natural function of native valves. They operate globally and foster a purpose-driven, collaborative culture across all locations. As the

Director of Regulatory Affairs , you will report directly to the SVP of Clinical and Regulatory Affairs and play a central role in shaping and delivering global regulatory strategy. This individual will lead the execution of regulatory submissions and compliance activities, partnering with cross-functional teams to ensure alignment with international requirements for both pre- and post-market activities. Key Responsibilities: Drive regulatory strategy development and execution across the full product lifecycle, in alignment with business priorities. Serve as the regulatory lead and subject matter expert for interactions with global health authorities, including the FDA and Notified Bodies. Build, mentor, and lead a high-performing global Regulatory Affairs team to support clinical and commercial objectives. Manage the planning and oversight of departmental resources and budget. Oversee the preparation, review, and submission of high-quality global regulatory submissions (e.g., IDEs, PMAs, MDR, CE Mark). Ensure timely renewals of product registrations, licenses, and global certifications. Collaborate with Quality Assurance to maintain ISO, CE, and other certifications and support audit readiness. Provide regulatory input during Engineering Change Requests (ECRs) and product modifications. Conduct global regulatory assessments, including reportability reviews, vigilance submissions, and corrective actions. Maintain audit-ready regulatory files and submission documentation for tissue-based Class III medical devices. Guide application of relevant standards (e.g., ISO 13485, QSR, GMP, GCP) across product development and documentation processes. Participate in or lead regulatory reviews of promotional and marketing materials. Author, review, and approve regulatory SOPs and internal processes to ensure compliance and efficiency. Qualifications: Bachelor’s degree in a technical, engineering, or scientific discipline; advanced degree strongly preferred. 10+ years of regulatory experience in the medical device sector, ideally with a focus on cardiovascular or structural heart products. Minimum 5 years in a leadership role managing regulatory affairs teams. Proven track record with Class III device submissions, including PMAs, IDEs, and EU MDR/CE Mark approvals. Deep familiarity with global regulatory frameworks (FDA, EU MDR, ISO 13485, QSR, etc.). Experience supporting Notified Body interactions and post-market surveillance requirements. Strong communication skills and the ability to translate complex regulatory requirements into actionable guidance. Excellent project management abilities with a results-driven, detail-oriented, and solution-focused approach. Apply today or reach out directly to rbanton@barringtonjames.com Seniority level

Seniority level Director Employment type

Employment type Full-time Job function

Job function Science, Strategy/Planning, and Writing/Editing Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Barrington James by 2x Inferred from the description for this job

Medical insurance Vision insurance 401(k) Pension plan Child care support Paid maternity leave Paid paternity leave Disability insurance Get notified about new Director of Regulatory Affairs jobs in

Minnesota, United States . Associate Director of Regulatory Affairs

Director of Regulatory Affairs - Medical Devices

Minneapolis, MN $165,000.00-$225,000.00 2 days ago Regulatory Affairs Specialist - Principal Specialist

Regulatory Affairs Specialist - Medical Devices

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