Senior Regulatory Affairs Lead, Medical Devices

Elevaris Medical Devices; Wilmington (MA); On-site; USD 123,000 - 150,000; Full time

Job summary

Elevaris Medical Devices seeks a Principal Regulatory Affairs Specialist to lead global regulatory strategies, drive complex submissions, and ensure lifecycle management for precision medical devices. You will partner with cross-functional teams across development, manufacturing, and quality to align regulatory objectives with business priorities.

Ideal candidates bring 8+ years in medical device regulation, extensive FDA submission experience (510(k), PMAs), and deep knowledge of FDA/EU MDR/ISO

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree preferred.
• 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.

Responsibilities

• Develop and lead regulatory strategies supporting 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 related to 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 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 business impact.
• Provide technical mentorship and leadership to Regulatory Affairs team members.

Skills

Regulatory leadership

FDA submissions

Regulatory strategy

Risk assessment

Cross-functional collaboration

Project management

Global regulatory compliance

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

RAC certification (preferred)

Tools

FDA regulatory knowledge

Job description

Elevaris Medical Devices seeks a Principal Regulatory Affairs Specialist to lead global regulatory strategies, drive complex submissions, and ensure lifecycle management for precision medical devices. You will partner with cross-functional teams across development, manufacturing, and quality to align regulatory objectives with business priorities.

Ideal candidates bring 8+ years in medical device regulation, extensive FDA submission experience (510(k), PMAs), and deep knowledge of FDA/EU MDR/ISO