Job Description
Regulatory Affairs Specialist – Medical Devices - $80k - $100k
US Citizens or Green card holders only
No C2C
An innovative medical device company is looking for a Regulatory Affairs (RA) Specialist to join their team. This role focuses on developing regulatory strategies, preparing U.S. and international submissions, and ensuring compliance for life-saving cardiac and vascular products.
Key Responsibilities:
- Define and execute regulatory strategies for submissions, including 510(k), IDE, PMA, EU/CE Technical Documentation Files, Canadian Licenses, and other international registrations .
- Manage amendments, supplements, renewals, annual reports, and responses to regulatory agency inquiries.
- Collaborate with global teams, regulatory partners, and cross-functional stakeholders to support regulatory approvals and market entry for new and existing products.
- Review and provide regulatory guidance on labeling, promotional materials, product changes, and documentation to ensure compliance.
- Maintain a deep understanding of global regulatory requirements and liaise with regulatory authorities as needed.
- Support regulatory compliance activities such as facility site registrations, audits, CAPAs, NCRs, post-market surveillance, and risk management .
- Develop and maintain regulatory processes, SOPs, and internal documentation to align with evolving global regulations.
Qualifications & Experience:
- Bachelor’s degree with at least two years of regulatory experience , or an advanced degree with at least one year .
- Experience with FDA Class II or III devices or EU Class IIb or III devices .
- Strong ability to interpret and apply regulatory requirements in a medical device or life sciences environment .
- Experience working in cross-functional teams with engineers, quality, and regulatory professionals.
- Excellent technical writing, communication, and project management skills .
- Ability to manage multiple regulatory projects simultaneously and meet tight deadlines.
Preferred:
- Experience with Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices, or human tissue regulations .
- Knowledge of global medical device regulations and submission pathways .
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