Quality & Regulatory Manager

The Quality & Regulatory Manager will be responsible for all aspects of the Quality Management System (QMS) and Information Security Management System (ISMS). This person shall ensure these systems are aligned to required ISO Standards, and that where applicable, the QMS is followed as part of product development.

This person will require a minimum of four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices, with a proven track record in regulatory submissions and ISO certifications. They will be responsible for leading a Quality team, and the organisation as it strives to deliver quality software within the In Vitro Diagnostic Industry.

About the role

This person will work with process owners to discuss and determine changes and updates to the QMS to ensure compliance. They will need to ensure they are up to date (and therefore the organization) with regulatory requirements and potential updates to them.

They will ensure project adherence to the Quality Management System through internal audits and project checkpoints.

This person will be responsible for working with the project and commercial team to define the product regulatory strategy and guide the team through regulatory assessments and classification. Furthermore they will be responsible for bringing project documentation together along with other information required for a regulatory submission, particularly to FDA and IVDR.

The Quality and Regulatory manager will manage relationships with customer Q&R teams, ensuring requests are reasonably managed and supporting customers in making quality and regulatory decisions throughout the project process.

Skills and experience

* Knowledge of FDA and FDA requirements in relation to software

* Knowledge of IVDR Regulation 2017/746

* Knowledge of UK Medical Device Regulation

* Knowledge of ISO 13485 (essential)

* Knowledge of ISO 14971, 27001 and standards IEC (phone number removed) (advantageous)

* Ability to convert regulatory requirements into relevant quality management processes and work instructions

* Strong stakeholder management

* Strong attention to detail with the ability to prioritise

* Min. 3 years’ experience of in-depth software quality management in a professional environment.

* Management of a Quality System to a recognized standard.

* Experience in regulatory submissions

* Experience in stakeholder management and team leadership

* Audit experienced/trained

* Formally educated to degree level in an IT based subject preferred but not essential.

* Prior experience within the medical sector would be advantageous

To £55,000. This is a home based role, although a midlands base would be ideal as there will be occasional travel to Burton on Trent, Staffordshire. Benefits include flexible working around core hours, 24 days holiday + 3 days for Christmas shutdown, contributory pension, death in service, cash health plan. Interested? Send your CV now