Quality and Regulatory Manager

  • Category
    Engineering - Manufacturing
  • Location
    Oxford, Oxfordshire
  • Salary
  • External Reference
  • OrganizationType

Adecco Life sciences are representing a Medical Device company based in Oxford looking for a Quality and Regulatory Manager to join the team on a permanent basis.
Reporting to the Head of Quality and Regulatory you will be leading a small but growing team supporting them with all aspects of the Quality Management System and regulatory growth.

Day to day will see you:

Evolve the Quality Management system to accommodate the product portfolio ensuring compliance to medical device standards and regulations (e.g., MDSAP, EU MDR, ISO 13485, etc.).
Review regulatory requirements, implementing strategies for submissions into the EU, US and emerging markets.
Prepare technical documentation for global submissions.
Identify compliance risks and escalate when necessary.

To be considered for the Quality and Regulatory Manager the candidate will be:

Self-motivated, with the ability to work proactively utilising their own initiative.
Have detailed knowledge of International Standards, Regulations, and Medical Devices Directives, and ability to interpret and apply GMP, guidelines, and best practices.
Able to interact with Senior Directors and board-level whilst communicating with junior candidates.
Have had previous experience collaborating with different departments and have worked within a management position for at least 3 years.

This position is looking for someone who will be happy to be onsite at least 3 days per week.
If you believe you have the right skill set and would like to apply, then please get in touch.

Spring acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Spring Group UK is an Equal Opportunities Employer.

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To speak to a recruitment expert please contact Amy Holder