Medical Device Regulatory Affairs Specialist

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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

• 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: 170703

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