Medical Device Regulatory Affairs Specialist - Cleveland - Goodwin Recruiting

    Goodwin Recruiting
    Goodwin Recruiting Cleveland

    1 week ago

    Full time
    Description

    ***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

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