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***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
JOB ID: 170811
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Michelle McAdoo