Medical Device Regulatory Affairs Specialist - RELO - Pittsburgh

Medical Device Regulatory Affairs Specialist - RELO - PITTSBURGH at Goodwin Recruiting summary:

Seeking a Regulatory Affairs Specialist to support regulatory submissions, compliance, and lifecycle management for implantable cardiovascular medical devices in Pittsburgh. Role requires 3–5 years' medical device regulatory experience, knowledge of FDA 21 CFR, ISO 13485, EU MDR, design controls, and experience with US/international submissions and technical documentation. Responsibilities include preparing filings, supporting audits/inspections, partnering with cross-functional teams, maintaining regulatory records, and assisting with export/import compliance and eQMS processes.

*** This job is in Pittsburgh***

We are seeking a driven, detail-oriented Regulatory Affairs Specialist to join our growing medical device team and support regulatory submissions, compliance initiatives, and full product lifecycle management for implantable cardiovascular devices. This is a hands‑on role for a motivated professional who excels in highly regulated environments, collaborates effectively across technical and clinical teams, and takes true ownership of their work. If you have a strong working knowledge of FDA and international regulatory requirements and are looking to build a long‑term career in Regulatory Affairs, we encourage you to apply.

Regulatory Affairs Specialist Benefits

• 100% top‑tier employee‑paid health, dental, and vision insurance
• 401(k) with 3.5% company match
• Flexible work environment with strong work/life balance
• 20 days PTO + 5 sick days
• Inclusive, collaborative, and equity‑focused workplace
• Low‑micromanagement, results‑driven culture
• Career growth within a growing organization

Regulatory Affairs Specialist Qualifications

• Bachelor’s degree in Engineering (Biomedical), Life Sciences, Regulatory Affairs, or related field
• 3–5 years of experience in medical device regulatory affairs
• Working knowledge of FDA 21 CFR, ISO 13485, EU MDR, and design controls
• Experience supporting US and international regulatory submissions
• Strong technical writing and documentation skills
• High attention to detail and strong organizational abilities
• Comfortable working independently in a fast‑paced environment
• Experience with cardiovascular or implantable devices preferred
• Familiarity with export/import regulations and eQMS systems is a plus

Regulatory Affairs Specialist Responsibilities Include

• Support regulatory pathways for new product introductions and design changes
• Assist in preparing and organizing US and international regulatory submissions
• Contribute to filing strategies, testing requirements, and standards alignment
• Maintain regulatory records, procedures, and submission archives
• Support compliance with FDA, ISO, and international regulations
• Assist with product registrations, renewals, and regulatory commitments
• Partner with Engineering, Quality, Manufacturing, and R&D to gather technical documentation
• Participate in design reviews and risk management activities
• Provide regulatory input on labeling, testing, and change management
• Support internal and external audits and regulatory inspections
• Assist with inspection preparation and agency responses
• Monitor regulatory changes and communicate potential impacts
• Support export and import compliance requirements
• Help resolve regulatory challenges using compliant, practical solutions
• Contribute to the continuous improvement of regulatory systems and workflows

medical device regulatory affairs, FDA 21 CFR, ISO 13485, EU MDR, regulatory submissions, implantable cardiovascular devices, design controls, eQMS, clinical and technical documentation