Principal Regulatory Affairs Specialist

Elevaris Medical Devices•Wilmington, MA

22h•$123,000 - $150,000

About The Position

The Principal Regulatory Affairs Specialist is the highest-level individual contributor within Regulatory Affairs. The role develops and executes global regulatory strategies supporting product development, registration, commercialization, market expansion, and lifecycle management of Elevaris products. It provides advanced regulatory leadership for complex projects, serves as a subject matter expert on U.S., EU, and international regulatory requirements, and partners with cross-functional teams to align regulatory objectives with business priorities. The position independently leads complex submissions, regulatory strategy, risk assessment, and agency interactions. It also mentors Regulatory Affairs team members and supports ongoing compliance with applicable global regulations. Success includes accurate, timely submissions; continued global product compliance; proactive identification and mitigation of regulatory risks; and regulatory strategies that support business growth and innovation. The role requires 10–15% domestic and international travel as needed, regular use of computer and communication tools, and the ability to work independently and/or as part of a team. Physical requirements may vary by role and location, and reasonable accommodation may be available in accordance with applicable local laws.

Requirements

Bachelor’s degree in a scientific discipline.
At least 8 years of progressive Regulatory Affairs experience in medical devices.
Experience leading FDA submissions, including 510(k)s.
Advanced knowledge of FDA, EU MDR, ISO 13485, and global regulatory requirements.
Strong project leadership, communication, and risk assessment skills.

Nice To Haves

Advanced degree.
RAC certification.

Responsibilities

Develop and lead regulatory strategies for new product development, product modifications, market expansion, and lifecycle management.
Serve as the primary Regulatory Affairs representative on cross-functional product development teams.
Provide regulatory guidance and risk assessments for design, manufacturing, supplier, and labeling changes.
Lead preparation and submission of 510(k)s, PMAs, IDEs, international registrations, renewals, and regulatory assessments.
Coordinate responses to regulatory agency requests and represent regulatory perspectives with the FDA, Notified Bodies, and global authorities.
Review and approve engineering changes, labeling, IFUs, promotional materials, and development documentation.
Develop and maintain Technical Files, Design History Files, and regulatory dossiers.
Monitor emerging regulations and assess their business impact.
Provide technical mentorship and leadership to Regulatory Affairs team members.
Independently make regulatory decisions within established frameworks and recommend regulatory strategies and risk mitigation approaches for complex projects.
Collaborate with Quality, R&D, Clinical Affairs, Manufacturing, Supply Chain, Marketing, and Commercial teams.