Regulatory Affairs Manager

Summary

The Regulatory Affairs Manager is an experienced individual contributor responsible for developing, executing, and maintaining global regulatory strategies to support the timely commercialization and continued compliance of medical device products. The role partners closely with cross‑functional stakeholders to ensure products meet applicable regulatory, quality, and safety requirements across global markets.

This role serves as a subject matter expert in global regulatory requirements, including U.S., EU, and international regulations, such as EU MDR, FDA requirements. The Regulatory Affairs Manager provides regulatory guidance across the product lifecycle, and may act as or support the Person Responsible for Regulatory Compliance (PRRC) or the EU Authorized Representative (AR), where assigned/based on location. The position promotes regulatory excellence through education, collaboration, and continuous improvement.

Responsibilities

Develop and implement global regulatory strategies and associated activities to support new product development, product lifecycle management, and global market access.

• Lead, prepare, review, and support regulatory submissions, registrations, renewals, and regulatory change notifications globally.

• Assess the regulatory impact of product, labeling, manufacturing, system, and data changes and secure timely regulatory approvals.

• Serve as a regulatory subject matter expert, providing interpretation of applicable regulations, standards, and guidance documents, possessing a deep understanding of medical device regulations, including but not limited:

•  US: 21 CFR Part 820  
• Canada: Medical Device Regulations SOR/98-282 
• EU: Medical Device Directive 93/42/EEC and Medical Device Regulations (2017/745) 
• Brazil: Classification and Registration Requirements of Medical Product RDC 185/2001 and GMP Requirements for Medical Devices and IVDs RDC 665/2022 
• Japan: Pharmaceutical and Medical Device Act (2014) 
• Australia: Therapeutic Goods (Medical Devices) Regulations 2002

• Support or perform PRRC or EU AR responsibilities, ensuring technical documentation, declarations of conformity, and compliance records are maintained.

• Collaborate cross‑functionally with R&D, Quality, Clinical, Labeling, IT, Operations, Marketing, and external partners (e.g. distribution partners)

• Lead or support regulatory compliance projects and continuous improvement initiatives.

• Prepare and maintain regulatory documentation, reports, and compliance records.

• Review and approve labels, instructions for use, and advertisement and promotional materials.

• Support post-market activities (i.e.non-conformances, risk assessments, complaints) and internal and external audits (i.e. EU MDR, MDSAP, ISO 13485, ISO 14971)

• Acts as a liaison with the government authorities.

• Develop and deliver regulatory training and education to internal stakeholders.

• Participate in industry working groups and monitor industry best practices as appropriate.

Essential Functions of the Role

Education & Work Requirements

Education & Work Preferences

• Master’s degree preferred.

• Equivalent combination of education and experience may be considered.

• Regulatory credential or equivalent preferred (such as RAC from RAPS)

Competencies