Head of Regulatory Affairs, North West, Medical Devices, £60-80k

Job Reference: #21872 Add to saved jobs

  • Location Manchester, North West, Liverpool, Cheshire, Lancashire, Chester
  • Permanent
  • Sector Medical Devices

Job Summary

Would you like the opportunity to head up a Regulatory team at a medical device company with global presence? Are you someone who would enjoy the continuous development of products through to full FDA and EU certification? If so, don’t hesitate to get in touch! Head of Regulatory Affairs, £60-80k, North West, Medical Devices Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Job Overview

• Provide project-specific Regulatory strategy to ensure a timely route to market.
• Prepare regulatory submissions where required and secure timely approvals.
• Liaising and negotiating with regulatory authorities.
• Maintain up-to-date knowledge of regulatory legislation, guidelines etc.
• Ensure the maintenance of all company’s Standard Operating Procedures in line with current legislation, regulatory authority guidance and best practice.
• Develop and implement plans to achieve department goals and strategies.

Skills Required

• Submissions to the EU, all classifications desired
• Regulatory submissions to the US including 510K (PMAs would be an advantage)
• Experience in leading a team with demonstrable process and project management to achieve targeted goals
• Pro-active leader of the team who can plan and implement the complex requirements of the changing regulatory environment to achieve the business needs

Contact Details

Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

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Find out more about us at www.peoplewithchemistry.com and https://www.linkedin.com/in/nathan-berkley-a25811139/

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