Job Description

Regulatory Affairs Specialist – Medical Devices

Salary: $75k - $95k

US Citizens or Green Card Holders Only

No C2C

A cutting-edge medical device company is seeking a Regulatory Affairs (RA) Specialist to join their growing team. This position plays a critical role in shaping regulatory strategies, managing U.S. and international submissions, and ensuring compliance for advanced cardiac and vascular products.

Key Responsibilities:

• Develop and implement regulatory strategies for submissions, including 510(k), IDE, PMA, EU/CE Technical Documentation Files, Canadian Licenses, and other international registrations.
• Handle amendments, supplements, renewals, annual reports, and responses to regulatory authority requests.
• Partner with global teams, regulatory agencies, and cross-functional stakeholders to drive market approvals for new and existing products.
• Provide regulatory guidance on labeling, promotional materials, product modifications, and documentation to ensure compliance.
• Stay up to date on evolving global regulatory requirements and serve as a liaison with regulatory authorities.
• Support compliance initiatives, including facility site registrations, audits, CAPAs, NCRs, post-market surveillance, and risk management.
• Establish and refine regulatory processes, SOPs, and internal documentation in alignment with global standards.

Qualifications & Experience:

• Bachelor’s degree with at least two years of regulatory experience, or an advanced degree with at least one year .
• Experience working 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.
• Proven experience collaborating with engineers, quality teams, and regulatory professionals.
• Excellent technical writing, communication, and project management skills.
• Ability to balance multiple regulatory projects and meet strict deadlines.

Preferred Qualifications:

• 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.

Job Tags

Similar Jobs