Regulatory Affairs Manager-Medical Devices

Jobgether; United States; Remote; USD 120.000 - 140.000; Vollzeit

Benefits dieser Stelle

Health and dental insurance options

401(k) retirement plan with employer

Employee Stock Ownership Plan (ESOP)

Generous paid time off (PTO)

Paid holidays and sick leave

Professional development funding

Zusammenfassung

Jobgether, a partner company, is seeking a Regulatory Affairs Manager – Medical Devices based in the United States. You will lead global regulatory strategies and ensure compliance across the product lifecycle.

Collaborate with Engineering, Quality, Product Development, and leadership to embed regulatory requirements in design and development, manage submissions, and support market access across international markets.

Qualifikationen

• Bachelor's in Engineering or life sciences.
• 7–10 years in medical device regulatory affairs.
• 3+ years of leadership or project management.
• Experience with FDA submissions and international registrations.
• Knowledge of FDA MDR UK Canada MDSAP.
• ISO 13485 QMS experience.
• Strong leadership and communication skills.
• RAC or CQE certifications preferred.

Aufgaben

• Develop global regulatory strategies for device lifecycle.
• Lead regulatory submissions and registrations.
• Advise leadership on regulatory risks.
• Mentor Regulatory Affairs team.
• Ensure QMS alignment with regulatory standards.
• Collaborate with engineering for compliant designs.
• Maintain relationships with authorities and notified bodies.
• Monitor regulatory changes and guidance.

Kenntnisse

Regulatory leadership

FDA submissions

Project management

Regulatory affairs

MDR knowledge

Quality Systems

Ausbildung

Bachelor's degree in Engineering

Master's degree preferred

Jobbeschreibung

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Manager – Medical Devices based in the United States. As a Regulatory Affairs Manager, you will lead global regulatory strategies and ensure compliance across the full lifecycle of medical devices.

You will play a key role in supporting product development, commercialization, international market access, and ongoing regulatory activities.

Working closely with Engineering, Quality, Product Development, and executive leadership, you will ensure regulatory requirements are integrated into business and product decisions.

You will oversee regulatory submissions, product registrations, and interactions with regulatory authorities and international stakeholders.

This position also offers the opportunity to lead and develop regulatory professionals while strengthening quality and compliance practices across the organization.

You will contribute to the development of innovative medical technologies within an established, collaborative, and innovation-driven environment.

The role is remote, with occasional onsite visits required to locations in Maine or Pennsylvania.

Accountabilities

• Develop and implement global regulatory strategies that support medical device product development, commercialization, market access, and lifecycle management.
• Provide regulatory leadership and guidance throughout all stages of product design, development, verification, validation, product release, and post-market support.
• Advise executive leadership on regulatory risks, business opportunities, emerging requirements, and their potential impact on organizational objectives.
• Lead, mentor, and develop Regulatory Affairs team members, fostering technical expertise and effective collaboration.
• Oversee the preparation, review, submission, and ongoing maintenance of regulatory filings and documentation across international markets.
• Ensure timely maintenance and renewal of product registrations, licenses, and approvals in all applicable markets.
• Manage communications and relationships with regulatory authorities, notified bodies, distributors, and international representatives.
• Ensure regulatory requirements are effectively integrated into the Quality Management System (QMS) and aligned with applicable standards.
• Participate in internal and external audits, supplier audits, and regulatory inspections, supporting readiness and timely resolution of findings.
• Collaborate with Engineering and Product Development teams to incorporate regulatory requirements into product designs and development activities.
• Review and approve product claims, labeling, instructions for use (IFUs), advertising, promotional materials, and marketing communications to ensure regulatory compliance.
• Participate in design reviews and product development projects as a key regulatory stakeholder.
• Monitor emerging regulations, guidance documents, international standards, and industry best practices to anticipate changes and maintain ongoing compliance.

Requirements

• Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Quality, or a related technical discipline.
• Master's degree in a relevant field is preferred.
• At least 7–10 years of professional experience in medical device regulatory affairs.
• Minimum of 3 years of leadership, supervisory, or project management experience.
• Demonstrated experience preparing and managing FDA regulatory submissions, international registrations, and global market access activities.
• Strong knowledge of regulatory frameworks and requirements across the FDA, European Medical Device Regulation (MDR), United Kingdom, Canada, and Medical Device Single Audit Program (MDSAP).
• Experience working with Class II and/or Class III medical devices is preferred.
• Previous experience in FDA-regulated environments and organizations operating under ISO 13485-certified Quality Management Systems is required.
• Strong understanding of medical device development processes, regulatory documentation, product lifecycle management, and post-market compliance.
• Proven ability to develop and execute regulatory strategies while balancing business objectives and compliance requirements.
• Excellent leadership, communication, and stakeholder management skills, with the ability to influence cross-functional teams and advise senior management.
• Strong analytical skills, attention to detail, and the ability to manage multiple regulatory projects and priorities effectively.
• Preferred certifications: Regulatory Affairs Certification (RAC), ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), or ISO 13485 Lead Auditor Certification.
• Ability to work remotely while remaining available for occasional onsite visits in Maine or Pennsylvania.

Benefits

• Annual salary: $120,000–$140,000.
• Remote work arrangement, with opportunities for hybrid work and occasional onsite collaboration.
• Flexible work schedule.
• Health and dental insurance options.
• 401(k) retirement plan with employer matching.
• Employee Stock Ownership Plan (ESOP).
• Generous paid time off (PTO).
• Paid holidays and sick leave.
• Up to $1,000 per year for approved professional development.
• Optional life insurance coverage.
• Health Savings Account (HSA) and Dependent Care Account (DCA) options.
• Opportunities for professional growth and continued development in the medical device and neuroscience industries.