- 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
- 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
- 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
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Medical Device Regulatory Affairs Specialist - Pittsburgh - Goodwin Recruiting
Description
We are adding a driven, detail-oriented Regulatory Affairs Specialist to our expanding medical device team to handle regulatory submissions, compliance activities, and product lifecycle management for implantable cardiovascular devices. This is a hands-on role for someone who thrives in regulated environments, collaborates well across functions, and takes ownership of their work. If you are confident in navigating FDA and international requirements and wish to grow long-term in Regulatory Affairs, apply today
Regulatory Affairs Specialist Benefits
Regulatory Affairs Specialist Qualifications
Regulatory Affairs Specialist Responsibilities Include
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Sr. Regulatory Affairs Specialist
Only for registered members Pittsburgh
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Sr. Regulatory Affairs Specialist
Only for registered members Pittsburgh, PA
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Sr. Regulatory Affairs Specialist
Only for registered members Pittsburgh
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Sr. Regulatory Affairs Specialist
Only for registered members Pittsburgh
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Sr. Regulatory Affairs Specialist
Only for registered members Pittsburgh, PA
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Senior Specialist, Scientific Affairs
GNC- Pittsburgh
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Sr. Regulatory Affairs Specialist
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Senior Specialist, Scientific Affairs
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FDA Regulatory Affairs Principal Specialist
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FDA Regulatory Affairs Principal Specialist
Full time Only for registered members Pittsburgh
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FDA Regulatory Affairs Principal Specialist
Only for registered members Pittsburgh, PA
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FDA Regulatory Affairs Principal Specialist
Only for registered members Pittsburgh, PA
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Paramedic, EMT-P,
Biolife Plasma Services- Pittsburgh
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Paramedic, EMT-P,
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Paramedic, EMT-P,
Biolife Plasma Services Careers- Pittsburgh
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Licensed Practical Nurse, LPN
Biolife Plasma Services Careers- Pittsburgh
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Licensed Practical Nurse, LPN
Biolife Plasma Services Careers- Pittsburgh
