Head of Regulatory & Quality Affairs

  • Company:
    Austin Vita
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    2 days ago
  • Category:

Austin Vita are excited to share with you this fantastic opportunity to become the Head of Regulatory & Quality Affairs for a medical device company in the Healthcare space.

The Role

As the Head of QA/RA, you will be given the opportunity to really make this role your own.

The successful candidate will be responsible for leading the companies Quality and Regulatory requirements across the full portfolio of products and will need to have extensive experience in leadership, FDA, 510k submissions and ideally exposure to Orthopaedic products

Key elements of the role:

  • Responsible for all company Regulatory affairs, device related regulatory and quality issues and internal quality systems.
  • To provide both Medical Device Regulatory and Quality Management consultancy for the business and its technical team.
  • Provide full support to the Technical Director in ensuring all products are compliant to the required regulations and processed through the quality system.
  • Maintain all the CE Technical Files in order to ensure compliance to all current Medical Device Regulations.
  • Ensure all new products meet regulatory compliance and technical files are prepared and reviewed by Notified Bodies in readiness for key product launch targets.

If you are a Head of Regulatory & Quality Affairs or looking for a fantastic career progression opportunity and meet the criteria listed, please APPLY NOW!

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

Reference: 41354935

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