Regulatory Affairs Specialist – Medical Devices

Job overview

The Regulatory Affairs Specialist – Medical Devices role is onsite in Norfolk, VA. Compensation is not specified. The specialist supports regulatory submissions and compliance for Instant Systems Inc.’s medical devices. The role works to secure 510(k) and NDA approvals by integrating regulatory requirements into project plans and ensuring submissions are accurate, complete, organized, and accessible. Through cross-functional guidance, regulatory strategy, and audit support, the specialist helps maintain compliance throughout the product lifecycle.

What you'll do

• Represent regulatory affairs and provide guidance to cross-functional teams
• develop regulatory and compliance strategies for new and modified medical devices
• prepare and submit applications and reports
• respond to regulatory agency information requests
• maintain knowledge of applicable regulations
• develop relationships with device reviewers
• maintain SOPs, work instructions, and policies
• communicate regulatory impact assessments and submission status
• support audits.

What we're looking for

Skills & competencies

regulatory affairs specialist

medical devices

norfolk va

instant systems inc

510(k) submissions

nda approval

usfda

regulatory compliance

product development

audit support

cross-functional collaboration

Work arrangement

• Weekend coverage required

Benefits & perks

• 401(k), medical, dental, and vision benefits, wellness program, life insurance, corporate events, skill growth opportunities, short-term disability, and advancement opportunities.

Why this role

Requires 3–5 years of relevant regulatory affairs experience, specifically compiling and submitting 510(k) applications; a relevant bachelor’s degree is preferred.

About the employer

Instant Systems Inc is hiring for this role. Industry: Surgical and Medical Instrument Manufacturing. Sector: 33.