We are supporting our client, a global player within the Medical Device sector as they expand their QA/RA team by hiring a new Quality and Regulatory Specialist to join during a continued phase of growth for the business.
This role offers a very flexible and hybrid working pattern, based in our clients head office in London. This can be suitable for candidates not only based in London/surrounding counties, but also those further afield who can commute into London 2 days per week. The 2 days you work in the office are completely flexible and up to you.
About the company you are joining:
A global Medical Device business, who manufacture and supply a diverse range of medical device products (Class I, Class IIa and Class III) as well as non-medical device products into the UK retail and wholesale markets.
Benefiting from a having a strong/core product portfolio established within the market - ranging from pain relief products to general safety products, and there are further plans to launch more new products into the market soon. About the Quality and Regulatory Specialist role:
The Quality and Regulatory Specialist is responsible for supporting the maintenance of quality and regulatory compliance for medical device products and non-medical device products.
Some of the key responsibilities for the Quality and Regulatory Specialist will involve the following:
Quality Management System (QMS) Maintenance - ensuring ISO 13485 compliance, reviewing internal procedures, documents and SOPS for approval by QA/RA Manager and supporting with both internal/external audits.
Batch release - conducting batch reviews and managing batch release to ensure compliance with regulatory standards.
Complaint Handling and Post-Market Surveillance - Manage all complaints to ensure timely resolution and continuous improvement. Collect and analyse data for post-market surveillance (PMS) and contribute to risk assessments.
Technical File/Documentation Maintenance - Maintain product technical documentation for ongoing product lines as well as drafting technical documentation for new products, ensuring that all documents remain compliant with regulatory requirements.
Client and Service Provider Inquiries - Respond to product-related queries from clients and service providers.
Quality Records Management - Maintain accurate and organised records related to staff training, product conformity files (PCF), deviations, and the quality manual. We are looking for candidates for the Quality and Regulatory Specialist role who can demonstrate the following:
Degree qualified in a Scientific discipline - Biomedical, Life Sciences or Regulatory Affairs.
Proven experience working within Quality Assurance or Regulatory Affairs within the Medical Device field.
Strong knowledge and understanding of ISO 13485 standards and Medical Device Regulation (MDR).
An adaptable personality with a can-do attitude and grasps new concepts quickly.
Enjoy working collaboratively with people in other areas of the business.
Familiarity with Post-Market Surveillance, Vigilance Reporting, Clinical Evaluation, Biological Evaluations, Complaint handling, and document control. What is on offer?
Basic salary - £50,000pa
Annual bonus
Private Healthcare & Dental Cover
Subsidised gym membership (up to £1,800 per annum) Keywords: Quality and Regulatory Specialist, Quality Specialist, Regulatory Specialist, QA/RA Specialist, Medical Devices
