Ian Grant

Ian Grant

0141 410 1005

ODx - Director of Regulatory and Quality Affairs

Based from their R & D centre in Inverness, ODx Innovations is developing innovative, rapid and cost effective point of care (POC) medical devices to help address the challenge of Antimicrobial resistance. The organisation now seeks to appoint a Director of Regulatory and Quality Affairs.

The role

This is a hugely exciting opportunity for an experienced Director of Regulatory and Quality Affairs to lead and develop the organisation's strategic and operational regulatory and quality affairs function.

You will have a wide range of duties and responsibilities including;

  • Directing all Regulatory and Quality management activities including recruitment, mentoring and development of staff
  • Supporting the Quality Manager to ensure operational activities meet company developmental and regulatory requirements
  • Design, implementation and maintenance of the ISO 13483 accredited QMS
  • Ensure all product development meets/ exceeds all regulatory, legal and legislative compliance requirements for the quality, safety and efficacy of the product
  • Achieving all relevant ODx process, product compliance certification and accreditation from the relevant Regulatory Bodies
  • Planning and development of product trials and interpretation of trial data
  • Establish and communicate high performance standards, define clear accountability, and lead all operational activities by adopting development and improvement strategies to exceed the company's goals through efficient & accurate processes and procedures.
  • Represent the company as a subject matter expert for regulatory and quality matters, and any internal & external audits and assume responsibility for the resolution of any audit deficiencies.

Degree qualified, ideally, possessing a post graduate qualification within a pharmaceutical discipline, you will be able to demonstrate proven experience as a Director of Regulatory and Quality Affairs, or similar role, within a successful Point Of Care (PoC) Medical Device organisation. You will have a wealth of experience in defining, developing and implementing Regulatory and Quality Affairs. In addition, you will have first class people management skills managing daily operational activities, preferably within an ISO 13485 accredited operation. Direct knowledge and experience within a PoC environment is highly desirable.

This is a genuinely outstanding opportunity, offers a highly competitive salary and benefits package in conjunction with affording the opportunity to work with an exciting, innovative scale up organisation at a key stage in their growth and development.

For an informal discussion or to make an application, please contact our retained consultant, Ian Grant, on 0141 410 1005 or email ian.grant@edenscott.com.

Apply now