Engineering
Role: Quality Assurance / Regulatory Affairs Manager – Maternity Cover (12 month contract)
Location: Herefordshire
Salary: Extremely competitive
The Role
Our client, a global Medical Device company, is currently seeking an experienced QA/RA Manager for an initial 12 month maternity cover contract.
To set, direct, and oversee policies on quality standards and regulatory compliance by coordinating efforts to influence new regulatory and quality requirements; interpreting new quality and regulatory requirements/trends as they relate to all operations; and, supporting and managing the firm’s relationship with external regulatory agencies.
Key responsibilities
* Prepare or assist with the preparation of regulatory submissions including, but not limited to: 510(k), PMA, IDE, IND, BLA, NDA, CE Marking, applications.
* Prepare or assist with the preparation of Clinical Evaluation Reports with input from scientists and clinicians.
* Review documentation, prepare a gap analysis and write documentation to fill those gaps for regulatory submissions.
* Submit and maintain regulatory documents as required
* Liaison with external organizations regarding Regulatory matters.
* Support firm’s product development process and programs.
* Ensure effective implementation and maintenance of Quality System appropriate to the products manufactured by and for the company, and compliant with the relevant requirements of FDA Quality System Regulations (21 CFR 820), ISO 13485, EU Medical Device Directive
* Ensure the quality of products through the establishment, monitoring, and enforcement of a Quality Management System in compliance ISO 13485:2003, the Medical Device Directive 93/42/EEC and 21CFR820 requirements.
* Management Representative – includes ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements.
* Conducting Internal Audits, Supplier Audits and External Audits
* Risk Management Team Member
Key skills and experience required:
* University degree
* Practise in medical device industry at least 3 years
* ISO 13485 training
* EU medical device directive training
* ISO 13485 Internal Auditor Training
* training of EN ISO 14791
* Microsoft Office experience
This is an exciting opportunity to join a global leader in medical devices, with potential for long term career opportunities.
For more information, please contact Westcott Search
Salary:
Job Type: Permanent
Location: Leominster, Herefordshire
To apply for this job please visit www.cv-library.co.uk.
