Director / Head of Quality and Regulatory PermanentDo you have quality management experience within the biopharmaceutical industry?Can you perform well in a fast paced environment?Can...
Head of QA/RA - Perm - 65-75K - Coventry - Medical Devices
Our client is a medical device company based in Coventry, you will be responsible for developing, maintaining and promoting the Quality Assurance and Regulatory Affairs strategy. You will ensure compliance to ISO 13485 FDA standards and in compliance with CMDCAS and also support regulatory efforts.
- To manage communication with our customers, Notified Bodies and other regulatory bodies to address Quality Assurance, Quality Management System and Regulatory Affairs issues and accreditations.
- In association with Regulatory Affairs colleagues, to prepare and manage the submission and manage the approval process for 510(k) filings, CE Mark Technical files and Design Dossiers and Canadian MDL .
- In association with Quality Assurance colleagues to work with an electronic document control system, supporting the management of drafting of documentation, approval, reviewing and implementation of internal QMS documentation in accordance with ISO13485, FDA CFR 820 part 21, MDD and Health Canada SOR-98-282.
Skills and Experience
- Minimum of 6 years' experience within Regulatory Affairs or Compliance and minimum of 4 years' experience of Quality Assurance in a Medical Device or IVD Environment
- A demonstrable strong working knowledge and experience of applying ISO 13485, FDA 820 part 21 and MDD standards and regulations within the Medical Device or IVD industries
- Significant experience of preparation of 510(k) submissions, CE Mark Technical files and Design Dossiers and Canadian MDL, preferably for higher classification devices
- Experience of the development and submission of Clinical Evaluation Reports and the management of regulatory aspects of clinical trials
- Expertise in Risk Management, specifically in relation to biocompatibility
If you feel you have the right skills and experience for this role please apply online or call 0161 868 2200
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.