Compliance Advisor II supporting enterprise - wide compliance operations at AltaMed. Involves audits, training, policy drafting, and compliance queries with healthcare focus.
DP
Hybrid Quality & Regulatory Officer – Maternity Cover, 12-month Fixed-Term
Posted last month
About the role
- Quality & Regulatory Officer ensuring compliance with quality and regulatory requirements for Medical Device Regulations at Vital Healthcare. Overseeing audits and supplier risk reviews to maintain standards.
Responsibilities
- To maintain & ensure compliance with quality system & regulatory requirements for Medical Device Regulations.
- Ensure compliance to current relevant regulations & standards as well as assessing the potential impact of new/updated regulations.
- Management of the Fannin (UK) Ltd (Clevedon) Quality Management System.
- Undertake an active role in internal and external audits (including notified body, supplier & distributor) Management of suppliers & completion of supplier risk reviews.
Requirements
- Maintain & ensure compliance with quality system & regulatory requirements for Medical Device Regulations
- Maintain an in-depth knowledge of the business, its products, regulatory requirements, suppliers, customers, and the market dynamics.
- Maintain & implement the local & group company policies and procedures.
- Conduct planning for the Quality department, in line with the company’s defined strategy
- Ensure compliance to current relevant regulations & standards
- Management of the quality management system: Compliance with relevant GMP, Quality systems and ethical standards
- Liaise with Notified Body/Competent Authorities for management of (re)certification & surveillance audits.
- Investigation of complaints, non-conformities and completing corrective & preventative actions
- Management and maintenance of risk file
- Support in planning and executing Notified Body audits
Benefits
- 3 days required in the office, 2 days can be worked from home
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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