About this opportunity
Skillcloud HCM lists this Director, Medical Writing (Regulatory) opportunity in bowdoin center, Maine. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Regulatory Affairs Manager
Regulatory Affairs Manager
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.
The Regulatory Affairs Manager is responsible for leading and overseeing the Companys 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.
\Health and Dental Insurance options
Employee Stock Ownership Plan
Generous PTO, holiday pay, paid sick time
Options for Life Insurance, HSA and DCA Accounts
Flexible work schedule with the opportunity for hybrid work 1-2 days/week
Bachelors degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical discipline required. 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 Class II and/or Class III medical devices preferred.
RAC (Regulatory Affairs Certification), ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 13485 Lead Auditor Certification preferred.
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
\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. 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.
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.