Principal Regulatory Affairs Specialist
Job Title: Principal Regulatory Affairs Specialist
Location-Type: Hybrid Preferred (Norcross, GA) – Open to remote or relocation for highly qualified candidates
Start Date: ASAP
Job Type: Direct Hire
Compensation Range: $100,000 – $130,000 annually bonus
Job Description:
Lead U.S. regulatory activities for pre-market submissions, ensuring full compliance with FDA requirements for IVD and medical device products.
Day-to-Day Responsibilities:
-
Develop regulatory plans for new and modified products
-
Author FDA 510(k)
-
Serve as regulatory representative on cross-functional design teams
-
Review technical documentation, product labeling, and commercial materials for compliance
-
Coordinate with internal teams and the FDA to ensure timely approvals
-
Prepare and review summary analytical and clinical reports
-
Support change management and documentation control processes
Requirements:
-
Must-Haves:
-
5 years' experience in regulatory affairs, ideally with IVD or medical devices
-
Minimum of 3 years regulatory experience; quality systems background acceptable
-
Strong FDA 510(k) experience (5–10 submissions preferred)
-
Understanding of QMS (including postmarket surveillance, documentation)
-
Strong English communication and technical writing skills
-
Bachelor's degree in Human or Physical Sciences (Master's preferred)
-
Self-starter with cross-functional collaboration skills
-
-
Nice-to-Haves:
-
Experience with labeling and regulatory compliance reviews
-
Blood banking or biologics knowledge
-
Small team project management experience
-
Recommended Jobs
Wide Format Service Manager
An international equipment manufacturer of wide format digital inkjet equipment is looking for a Latin American Service Manager to be based out of their offices in Atlanta, GA. This equipment manufac…
National Accounts Manager, NMD - Northeast US
Additional Location(s): US-MA-Boston; US-CT-Danbury/Bridgeport; US-CT-Hartford; US-CT-New Haven; US-CT-Southeast/New London; US-CT-Stamford; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-M…
Assistant Manager Opportunity- Douglas
Management careers available for Assistant Managers * Create relationships with your staff and customers. • Meet goals through strategic planning and collaboration. • Juggle a range of responsi…
Sr. SAP Cloud ERP Sales Specialist - South
We help the world run better At SAP, we keep it simple: you bring your best to us, and we'll bring out the best in you. We're builders touching over 20 industries and 80% of global commerce, and w…
Respiratory Therapist, PRN, Days
Responsibilities: Respiratory Therapy at Piedmont Walton — Where Your Skills Make a Daily Impact At Piedmont Walton, a 77-bed community hospital with a 15-bed Emergency Department and 8-bed ICU, o…
IT/OT Third Party Risk Management Leader
Graphic Packaging International, LLC (GPI) fosters a culture that protects, preserves, and enhances our reputation. The GPI IT Compliance team is seeking an experienced professional to oversee and …
CDL Driver & Warehouse Associate
LOCAL WAREHOUSE DRIVER & ASSOCIATE PAY: ~$22/hr - weekly pay ~ Overtime at time and a half SCHEDULE: Home Daily Mon - Fri, 7am - 4 pm Saturdays required as needed Ov…
Tax Associate/Tax Senior 3946
Job Description As a Senior Tax Associate, you will prepare tax returns for personal, business, and non-profit clients. RML offers competitive compensation and great benefits with career advising …
TURBINE MX CREW CHIEF
Job Description Job Description Job Description Job Title: Crew Chief Department: Maintenance Job Description: # Purpose: Perform and supervise periodic and progressive inspect…