Head of Regulatory Affairs & Quality Assurance
Head of Regulatory Affairs & Quality – IVD
Our client is a well-funded, growing IVD developer looking to secure a Head of Regulatory and Quality in a newly created role.
This is a highly attractive opportunity focused on establishing and growing a regulatory and quality function with direct line management responsibilities. This position has significant focus on global regulatory submissions as well as the development and maintenance of the company’s QMS (in accordance with ISO 13485).
Our client is looking for a Head of Regulatory & Quality with significant and detailed knowledge of the regulatory process for global registrations of IVD products.
If you are a regulatory and quality expert with strong knowledge within the diagnostics industry looking for a progressive leadership role, please apply today.
Location: Cambridge – remote with occasional office visits as required
Ideal applicant:
1. Hands-on, QA/RA leader with strong and thorough ISO 13485 experience.
2. Strong experience within IVD / Diagnostics with a focus on global regulatory submissions and strategy setting.
3. Strong regulatory submission experience within IVD/Diagnostics products.
4. Degree level education or equivalent work experience.
5. Background within a commercial laboratory setting – advantageous but not essential.
6. Experience in a direct line management role (ideally within a diagnostics / medical device company).
7. Experience of implementing and managing a QMS – ISO 13485.
8. Excellent communication, presentation and influencing skills.
9. Experience of training and supporting a growing team.
Job role:
This role has responsibility for an existing team of 3 quality assurance personnel with plans for further growth. The key focus for this role is the management responsibility for the development and maintenance of the company quality policy in accordance with ISO 13485 as well as responsibilities for global regulatory submissions. Main duties to include:
1. Directing, planning, implementation and maintenance of quality control methods, processes and operations for all diagnostic products.
2. Management of regulatory authority inspections in accordance with ISO 13485.
3. Development and maintenance of a robust Quality Management System (QMS).
4. Management and coordination of CAPAs, deviation, management review, change management, document control, complaints, internal and external auditing and quality training.
5. Coordination and approval of SOPs, standard forms and protocols.
6. Oversee maintenance of non-conformance reports database and onward management of NCR reports.
7. Close liaison with product development teams to focus on continual improvements.
8. Management of supplied materials and resolving any issues.
9. Support product lifecycle in accordance with ISO 13485.
10. Provide regulatory leadership to cross-functional teams.
11. Develop and execute regulatory project plan for submissions.
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