Regulatory Affairs Manager

Kmaconsultingllc; Greenville (PA); Hybrid; USD 120.000 - 140.000; Vollzeit

Benefits dieser Stelle

Health and dental insurance

401K with company match

Employee Stock Ownership Plan

Professional development allowance

Life Insurance, HSA and DCA

Zusammenfassung

FHC, Inc. is seeking a Regulatory Affairs Manager to lead global regulatory activities and ensure compliance across markets.

The role supports product development, market access and post‑market compliance with a strategic regulatory plan. The ideal candidate will have 7–10 years in medical device regulatory affairs, leadership experience, and strong knowledge of FDA submissions, MDR/UK/Canada/MDSAP requirements.

Qualifikationen

• Bachelor’s degree in engineering or life sciences required; regulatory affairs or quality field preferable.
• Minimum 7–10 years of medical device regulatory affairs experience.
• 3+ years in leadership, supervision, or project leadership roles.
• Experience with FDA submissions, international registrations, and global market access.

Aufgaben

• Develop and implement global regulatory strategies for product development, commercialization and lifecycle management.
• Provide regulatory leadership across design, development, verification, validation, release and post‑market support.
• Advise executives on regulatory risks, opportunities and emerging regulations.
• Lead, mentor and develop Regulatory Affairs personnel.
• Oversee preparation, review, submission and maintenance of regulatory filings.
• Ensure timely maintenance of product registrations in all markets.
• Collaborate with Regulatory authorities, notified bodies, distributors and international reps.
• Integrate regulatory compliance into the Quality Management System (QMS).
• Participate in audits and regulatory inspections.
• Collaborate with Engineering to incorporate regulatory requirements into designs.

Kenntnisse

Regulatory leadership

FDA submissions

Global market access

Leadership experience

Regulatory strategy

Ausbildung

Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Quality, or related discipline

Master's degree preferred

Tools

GxP awareness

QMS ISO 13485

Jobbeschreibung

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
• 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.

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.

FHC, Inc is an 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.