* Leading surgical medical device organisation, home to an innovative portfolio * Competitive salary package, further benefits* Opportunity for growth and progression
SRG partner with an innovative leader in the medical device space, specialising in surgical based products. Now distributing products globally, with a strong pipeline to bring to market, they are hoping for a QARA Manager to join their team.
Responsibilities * Management Representative for Quality Management System, encompassing: Establishing, implementing and maintaining processes, insight on QMS improvement* Promoting the awareness of regulatory and customer requirements throughout the organisation* Liaison with external parties on matters relating to the QMS* Act as nominated Sterilisation specialist* Ownership of CAPA system* Overall responsibility the implementation and maintenance for the QMS* Person responsible for regulatory compliance (ref MDR 2017/745)* Working towards the achievement of the relevant company quality objectives * Compilation of technical files and regulatory submissions* Compliance overview for design and development projects* Defining quality requirements for external suppliers and ensuring that these are met
Skills and Experience
* Experience in medical device regulation and related quality management system compliance especially in an EN ISO 13485/ 21 CFR 820 and EN ISO 14971 framework* Extensive experience of the Medical Device Directive (93/42/EEC) and the Medical Device Regulations (2017/745)* Experience in United States Food and Drug Administration (510k) and CE Marking regulatory submissions* Experience of notified body audit / FDA inspections and/or regulatory body engagement* Lead auditor training* Statistical techniques and formal problem solving* Sterilisation validation (EO)
Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.
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