Head of Medical Regulatory Strategy

4 days ago


Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time
Key Responsibilities

As our ideal candidate, you will have a strong background in IVD medical device product development and a deep understanding of global medical device directives.

You will be responsible for leading our regulatory efforts, developing and implementing regulatory strategies to support new product development and commercialisation.

You will also oversee a team of regulatory professionals to ensure compliance with international medical device directives and regulations.

About the Role:

  • Develop and implement regulatory strategies to support NPD and commercialisation.
  • Lead a team of regulatory professionals to ensure compliance with global medical device regulations.
  • Liaise with regulatory authorities to ensure timely and compliant submissions.

About You:

  • A minimum of 5 years' experience in IVD medical device product development, adhering to standards such as ISO14971.
  • In-depth knowledge of global medical device directives, including FDA regulations, MEDDEV guidelines, and ISO standards.

What We Offer:

  • An estimated salary range of £80,000 - £110,000 per annum.
  • The opportunity to work on cutting-edge cancer diagnostic technology.
  • A dynamic and collaborative working environment.

Benefits:

A comprehensive benefits package, including health insurance, pension scheme, and annual leave.



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