🕒 11 days ago
Lead product quality and regulatory compliance for complex hardware, software, and AI systems, guiding global market access, team growth, and quality improvements from field findings through product design.
Regulatory Affairs Manager
🕒 10 days ago
Global Regulatory AffairsMedical Device RegulationsRegulatory StrategyFDA Submissions
📜 Description
- Guide regulatory activities across 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 regulatory filings and maintain product registrations across approved markets.
- Manage interactions with regulatory authorities, notified bodies, distributors, and international representatives; integrate compliance into the QMS and support audits and inspections.
🛠️ Requirements
- Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical discipline required. Master's degree preferred.
- Minimum of 7-10 years of medical device regulatory affairs experience.
- Minimum of 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.
- Experience with Class II and/or Class III medical devices preferred.
- Experience supporting ISO 13485-certified and FDA-regulated environments required.
- RAC (Regulatory Affairs Certification), ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 13485 Lead Auditor Certification preferred.
✨ Benefits
- Salary in the range of $ 120-140K
- Health and Dental Insurance options
- 401K with company match
- Employee Stock Ownership Plan
- Generous PTO
- Holiday pay
- Paid sick time
- Up to $1000/ 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/week
Full job description
FHC, Inc
Regulatory Affairs Manager
Bowdoin, Maine OR Greenville, PA (Hybrid)
FHC, Inc is searching for a Regulatory Affairs Manager to be based in New England or Western Pennsylvania and work hybrid with the ability to be onsite in Bowdoin, Maine or Greenville, PA as needed. FHC, Inc. has served the neuroscience community for over 50 years. With a guiding principle of innovation through collaboration, FHC designs, manufactures, and internationally markets products that provide customizable, pioneering solutions for neuroscientists, neurologists, and neurosurgeons and has been recognized on the Best Places to Work in Maine list for 2026.
Job Summary:
The Regulatory Affairs Manager is responsible for leading and overseeing the Company's global regulatory affairs activities to ensure compliance with applicable medical device regulations and standards in all markets where products are manufactured, marketed, distributed, or sold. This position develops and executes regulatory strategies that support product development, market access, business growth, and post-market compliance activities.
What We Offer:
-
Salary in the range of $120-140K
-
Health and Dental Insurance options
-
401K with company match
-
Employee Stock Ownership Plan
-
Generous PTO, holiday pay, paid sick time
-
Up to $1000/ 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/week
Qualifications:
-
Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical discipline required. Master's degree preferred.
-
Minimum of 7-10 years of medical device regulatory affairs experience.
-
Minimum of 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.
-
Experience with Class II and/or Class III medical devices preferred.
-
Experience supporting ISO 13485-certified and FDA-regulated environments required.
-
RAC (Regulatory Affairs Certification), ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 13485 Lead Auditor Certification preferred.
Responsibilities:
-
Develop and implement global regulatory strategies that support product development, commercialization, and lifecycle management of medical devices.
-
Provide regulatory leadership and guidance throughout all phases of 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 ensure regulatory requirements are appropriately incorporated into product designs.
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Provide regulatory review and approval of product claims, labeling, instructions for use, advertising, promotional materials, and marketing communications.
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Support design reviews and development projects as a core regulatory stakeholder.
-
Maintain awareness of emerging regulations, guidance documents, standards, and industry best practices
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