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Senior Manager, Regulatory Affairs
Location
United States
Posted
14 days ago
Salary
$144.6K - $216.9K / year
Seniority
Senior
Job Description
Senior Manager, Regulatory Affairs
Merative
• Leads global regulatory strategy and compliance for Merge Healthcare’s medical imaging portfolio, including Software as a Medical Device (SaMD) • Develops and maintains global regulatory strategies regulated medical devices and related imaging solutions • Provides leadership and expert guidance on current, new, and emerging regulations, standards, and guidance applicable to Merge Healthcare’s regulated and non-regulated enterprise imaging solutions • Oversees global product registrations, establishment listings or facility registrations where applicable, device licensing, certification, and market authorization activities for regulated medical devices and related imaging solutions, including entry requirements for new countries or regions • Serve as primary liaison with regulatory authorities, notified bodies, and approved bodies for submissions, pre-submissions, deficiency responses, technical documentation reviews, adverse event reporting, recalls, inspections, and compliance matters • Partners with Quality, Product, Engineering, and Customer Support teams on compliance issues, complaints, CAPAs, field issues, and customer or regulatory inquiries to assess regulatory reporting, market action, and authority communication requirements • Monitors regulatory changes and ensures timely implementation across processes and products • Supports post-market surveillance, vigilance reporting, complaint trend review, software anomaly assessment, cybersecurity vulnerability response, field action planning, and recall regulatory strategy for regulated medical devices and related imaging solutions
Job Requirements
- 10+ years of experience in medical device regulatory affairs, healthcare technology, life sciences, or a similarly regulated industry
- At least 8 years leading and managing teams in a medium-to-large organization in a regulated industry strongly preferred.
- Bachelor’s degree in a scientific or technical discipline required, or equivalent experience.
- Professional medical device certification preferred, such as Regulatory Affairs Certification (RAC).
- Demonstrated experience building and leading high-performing regulatory teams and programs by developing talent, strengthening succession plans, standardizing regulatory assessment processes, improving submission quality and timeliness, and representing Regulatory Affairs in portfolio and release governance.
- Specific experience with SaMD/software medical devices, including working knowledge of software lifecycle, risk management, usability, clinical/performance evaluation, and cybersecurity expectations under applicable standards and guidance such as IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, and applicable regulatory guidance.
Benefits
- Remote first / work from home culture
- Flexible vacation to help you rest, recharge, and connect with loved ones
- Paid leave benefits
- Health, dental, and vision insurance
- 401k retirement savings plan
- Infertility benefits
- Tuition reimbursement, life insurance, EAP – and more!
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