Vakula Technologies Inc

Senior Regulatory Affairs Specialist

Vakula Technologies Inc United States
Vakula Technologies Inc

Senior Regulatory Affairs Specialist

Vakula Technologies Inc United States
3 weeks ago 170 applicants

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Job Role: Senior Regulatory Affairs Specialist

Contract: W2

Location: Remote

Responsibilities

  • Develop and execute regulatory strategies for pioneering medical devices.
  • Provide expert guidance and support in obtaining regulatory approvals and clearances for Class II & Class III devices.
  • Collaborate with other areas in business such as Quality, R&D, and Clinical departments.
  • Prepare with the team for meetings with FDA and Notified Bodies.
  • Contribute towards submissions and regulatory files.
  • Engage with regulatory authorities and agencies to facilitate product approvals and resolve regulatory issues.

Qualifications

  • 3+ years working in Regulatory Affairs with Medical Devices (Orthopedic implantable devices highly preferred).
  • Demonstrated excellent communication and presentation skills.
  • Detailed knowledge of FDA, EUMDR, and Health Canada Regulatory Requirements.
  • Experience preparing for meetings with FDA and Notified Bodies.
  • Contributed to regulatory projects (510k, De Novo, IDE, PMA, and CE Mark).
  • Extensive knowledge of regulations, such as: ISO 13485, ISO 62304, CFR 820, ISO 60601-1.

  • Seniority level

    Associate

  • Employment type

    Contract

  • Job function

    Legal

  • Industries

    IT Services and IT Consulting

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