The role will suit an individual who can quickly build professional working relationships, work within a team across all functional units, and enjoys working in an agile environment.
You will ensure continued compliance of the Quality Management System procedures and records to harmonised standards and regulatory requirements.
- Determine all regulatory compliance requirements and related issues
- Plan and coordinate all aspects of Regulatory Compliance
- Develop and maintain the Quality Management System Submission files DMR DHF
- Manage the Audit process and perform Supplier Audits, Internal Audits and Technical File Audits
- Liaise with Certification Companies, Notified Bodies and Regulatory Authorities
- Co-ordinate and support on-site audits conducted by external providers and follow up on findings
- Create and maintain an internal risk assessment framework
- Manage corrective and preventive actions (CAPAs) and lead CAPA teams as necessary
- Aid the development and training of cross functional teams in all aspects of QMS
- The successful candidate will be able to demonstrate a proven track record in a similar role.
- Demonstrate experience and skills to interpret international Regulatory Requirements, apply them to our innovative field of business and embed them in the organisation.
- Demonstrate an ability to work collaboratively with stakeholders from diverse functional units.
- Has experience with managing QMS projects, providing training and coaching for all quality and regulatory related tasks.
- Primary Degree in a scientific or technical discipline
- 5 years’ experience in a similar role
- Proven track record in ensuring compliance with ISO13485:2016 and EN 62304
- Medical Device Directive (93/42/EEC) — full Technical File preparation including authoring Clinical Evaluations
- CE Marking new products
- FDA QSR 21 CFR part 820
- Experience of Risk Management techniques compliant with ISO 14971
- Implementing and ensuring timely completion of CAPAs arising from internal or external audits.
- Excellent communication and interpersonal skills.
Some travel within the UK will be a requirement of the job role. Occasional international travel may also be required.
If you are interested in this role please click “apply” now!
Harris Lord is acting as an employment agency for this role
Contact: Mark Bux-Ryan
Keywords: Key words Quality/regulatory/13485/14971/62304/ISO13485/ISO14971/EN62304/FDA/submission
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