Medical Device Regulatory Affairs Specialist - RELO - Pittsburgh

*** 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 xrlwcon 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