Regulatory Affairs Manager
About The Position
FHC, Inc. is seeking a Regulatory Affairs Manager to be based in New England or Western Pennsylvania. The role is hybrid, with the ability to work onsite in Bowdoin, Maine, or Greenville, Pennsylvania, as needed. The Regulatory Affairs Manager leads and oversees the company's global regulatory affairs activities, ensuring compliance with applicable medical device regulations and standards in markets where products are manufactured, marketed, distributed, or sold. The manager develops and executes regulatory strategies that support product development, market access, business growth, and post-market compliance. FHC designs, manufactures, and internationally markets products for neuroscientists, neurologists, and neurosurgeons, and has served the neuroscience community for over 50 years.
Requirements
- Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Quality, or a related technical discipline.
- At least 7 years of medical-device regulatory affairs experience; the posting specifies a minimum of 7–10 years.
- At least 3 years of leadership, supervisory, or project leadership experience.
- Demonstrated experience with FDA submissions, international registrations, and global market-access activities.
- Experience with FDA, MDR, UK, Canada, and MDSAP requirements.
- Work experience supporting ISO 13485-certified and FDA-regulated environments.
Nice To Haves
- Master's degree.
- Experience with Class II and/or Class III medical devices.
- RAC (Regulatory Affairs Certification).
- ASQ Certified Quality Auditor (CQA).
- ASQ Certified Quality Engineer (CQE).
- ISO 13485 Lead Auditor Certification.
Responsibilities
- Develop and implement global regulatory strategies supporting medical-device product development, commercialization, and lifecycle management.
- Provide regulatory leadership and guidance throughout product design, development, verification, validation, release, and post-market support.
- Advise executive leadership on regulatory risks, opportunities, emerging regulations, and business impacts.
- Lead, mentor, and develop Regulatory Affairs personnel.
- Oversee preparation, review, submission, and maintenance of regulatory filings.
- Ensure timely maintenance of product registrations in all approved markets.
- Manage interactions with regulatory authorities, notified bodies, distributors, and international representatives.
- Ensure regulatory compliance is integrated into the Quality Management System (QMS).
- Participate in internal audits, external audits, supplier audits, and regulatory inspections.
- Collaborate with Engineering and Product Development teams to incorporate regulatory requirements into product designs.
- Provide regulatory review and approval of product claims, labeling, instructions for use, advertising, promotional materials, and marketing communications.
- Support design reviews and development projects as a core regulatory stakeholder.
- Maintain awareness of emerging regulations, guidance documents, standards, and industry best practices.
Benefits
- Salary range of $120,000–$140,000.
- Health and dental insurance options.
- 401(k) with company match.
- Employee Stock Ownership Plan.
- Generous paid time off, holiday pay, and paid sick time.
- Up to $1,000 per year for approved professional development.
- Options for life insurance, HSA, and DCA accounts.
- Flexible work schedule with the opportunity for hybrid work 1–2 days per week.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
