Quality Assurance and Regulatory Affairs ManagerMedical Devices Essex PermanentAttractive remuneration packageRole requirements:Maintaining, championing and developing the compliance and effectiveness of the Business Quality Management System...
Quality Assurance and Regulatory Affairs Manager
Medical Devices - Essex - Permanent
Attractive remuneration package
Maintaining, championing and developing the compliance and effectiveness of the Business Quality Management System of the organisation. Driving a culture of continuous improvement and responsibility amongst all employees.
Duties will include:
- Working alongside Technical Director to plan the quality and regulatory strategy for the business.
- Provide strong leadership to the Quality and Regulatory teams as well as quality/regulatory input into the NPD/EPD processes.
- Responsible for managing and maintaining compliance to the applicable medical devices regulations and also with respect to ISO 9001 AND ISO 13485 certifications. Acting as the contact between the business and the national competent authorities and notified body.
- Renewals and applications for product registration and licences.
- Review meetings with Management and reporting on the overall effectiveness and improvements recommended for BQMS.
- Hosting of client and 3rd party audits as well as taking responsibility for internal auditing.
- Submission of technical files for manufactured products and evaluating and reporting to relevant authority any concerns arising from customer complaints including product failure and quality issues.
- Periodic review of procedures and recommending improvements of changes on a continual basis. Review and approval of the product labelling and marketing materials to ensure compliance with the regulatory bodies.
- Strong, relevant background from a manufacturing environment within a regulated industry (medical, lab, drug) and a good working knowledge of Medical Device Regulations (EU/Global) is essential.
- Knowledge of international, harmonised standards such as ISO 9001, 13485, 14971, EN 62366. Skilled and knowledgeable in regards QMS or supplier audits.
- Relevant degree (or equivalent) within areas such as Management, Manufacturing, Law or related.
- Excellence in report writing, constructing sound arguments both verbally and in writing and able to work in a collaborative manner using strong influencing skills.
- Analytical by nature, seeking responsibility and able to generate support for change with strong negotiation and influencing skills.
If this sounds like the next role for you in your QA/RA career then please attach your relevant CV, demonstrating your key skills, experience and achievements. We'll be in touch!
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.