Senior Manager in Regulatory Affairs overseeing submission management and regulatory compliance. Leading cross - functional teams in a neuroscience - focused biopharmaceutical environment.
DP
Hybrid Quality & Regulatory Officer – Maternity Cover, 12-month Fixed-Term
Posted 2 months ago
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
Local Compliance & Ethics Officer at Teva Germany serving local management and compliance program. Leading compliance initiatives and collaborating with various stakeholders while managing risks and providing guidance.
Manager of Asset Strategy and Regulatory Compliance driving asset management goals for Eversource. Ensuring regulatory compliance and system performance for electric transmission and substations.
IT Governance, Risk and Compliance Analyst managing compliance initiatives like NIST and ISO standards in technology and security operations.
Compliance Specialist overseeing regulatory adherence for youth programs in Gainesville. Ensuring DCF compliance and supporting youth program safety and integrity.
Technologist at FortisBC ensuring compliance with BCUC Critical Infrastructure Protection Standards. Focus on integrating business technology and providing technical support.
Compliance Examiner Business Lead at Freddie Mac conducting on - site examinations and ensuring financial activities align with laws. Engaging with financial institutions to enhance operational effectiveness.
Compliance Professional supporting Freddie Mac's investment and ethics policies. Engaging with compliance risks and overseeing regulatory obligations to promote best practices.
Compliance Officer at Hewlett Packard Enterprise ensuring adherence to compliance regulations, managing AML programs, and conducting risk assessments. Driving compliance culture across markets and delivering training to employees.
Risk Manager at Cisco Capital ensuring regulatory compliance and effective risk management practices. Focus on safeguarding financial health and collaboration within an international environment.