Regulatory Affairs Manager

Skillcloudhcm

Bowdoin, ME

Hybrid

Who this role is best for

Candidates with medical device regulatory expertise and leadership experience will find this hybrid role in neuroscience-focused product development and global compliance management in Bowdoin, Maine or Greenville, PA.

Best fit for

Candidates with 7-10 years of medical device regulatory experience and leadership roles in product lifecycle management
— “Minimum of 7-10 years of medical device regulatory affairs experience.”
Individuals who have managed FDA submissions and international regulatory requirements for Class II and III devices
— “Demonstrated experience with FDA submissions, international registrations, and global market access activities.”
Professionals with strong knowledge of ISO 13485 and experience in FDA-regulated environments
— “Experience with FDA, MDR, UK, Canada, and MDSAP requirements.”

Things to consider

The role may require travel between Bowdoin, Maine and Greenville, PA based on on-site needs
— “work hybrid with the ability to be onsite in Bowdoin, Maine or Greenville, PA as needed.”

How to stand out

Highlight experience with global regulatory strategies and product lifecycle management in your resume and interview responses
— “Develop and implement global regulatory strategies that support product development, commercialization, and lifecycle management of medical devices.”
Emphasize your ability to mentor and lead regulatory affairs teams in your application materials
— “Lead, mentor, and develop Regulatory Affairs personnel.”
Demonstrate your ability to integrate regulatory compliance into Quality Management Systems
— “Ensure regulatory compliance is integrated into the Quality Management System (QMS).”
Include examples of how you have supported design reviews and worked with engineering teams on regulatory requirements
— “Collaborate with Engineering and Product Development teams to ensure regulatory requirements are appropriately incorporated into product designs.”

Pace · SteadyCollaboration · HighAutonomy · MediumDecision Impact · Company

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

develop and implement global regulatory strategies
lead and oversee regulatory affairs activities
advise executive leadership on regulatory risks

Typical background

7-10 years of medical device regulatory affairs experience3 years of leadership, supervisory, or project leadership experience

Skills & requirements

Required

Medical Device Regulatory AffairsFDA SubmissionsInternational RegistrationsGlobal Market AccessISO 13485-certified Environments

Preferred

RACASQ Certified Quality AuditorASQ Certified Quality EngineerISO 13485 Lead Auditor Certification

Stack & domain

FDA SubmissionsInternational RegistrationsGlobal Market Access ActivitiesISO 13485-certifiedFda-regulated EnvironmentsRACASQ Certified Quality AuditorASQ Certified Quality EngineerISO 13485 Lead Auditor CertificationLeadershipSupervisoryProject LeadershipCommunicationCollaborationOrganizational SkillsMedical DeviceRegulatory Affairs

About the role

Original posting from Skillcloudhcm via Lever

FHC, Inc
Regulatory Affairs Manager
Bowdoin, Maine OR Greenville, PA (Hybrid)
FHC, Inc is searching for aRegulatory Affairs Managerto 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.
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
Skillcloud HCM Solutions has been engaged to manage this search. NO PHONE CALLS OR RECRUITERS PLEASE
I certify that the information contained in this application and resume is accurate and complete to the best of my knowledge. I understand that providing false, misleading, or incomplete information may result in the denial of employment or termination of employment if hired.
Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, ancestry, familial status, age, physical or mental disability, pregnancy, sexual orientation, gender identity, genetic information, veteran status, or any other characteristic protected by law.

Source: Skillcloudhcm careers (Lever)