Regulatory Affairs Manager

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

Additional information