Quality & Regulatory Affairs Manager
Job Title: Quality & Regulatory Affairs Manager
Location: Near Chelmsford
Salary: £58k - £70k
My client is looking for a Quality and Regulatory Affairs Manager who has experience in the medical devices industry.Job responsibilities
- You will be responsible for aligning the company's business needs to regulatory and legislative change.
- You will manage the Quality and Regulatory staff in maintaining the quality management system in accordance with the company strategy, policy and regulatory requirements.
- You will be accountable for ensuring product and regulatory compliance is achieved in all products and supporting documentation.
- Ensure that all staff, including Office staff, Directors, Business Development Representatives, Distributors Suppliers and Sub-Contractors are fully aware of their regulatory responsibilities and ensure adherence to them on a continual basis
- Review and assessment of the company Technical files and design dossiers
- Manage international product submission and continual registration
- Determine reportable events / incidents and advice the managing director accordingly. Manage any adverse incidents and communicate all relevant parties as necessary to bring incident to satisfactory conclusion
- Manage audit schedule, conduct audits or write audit reports and close out CAPA actions where applicable.
- Manage potential and existing suppliers/sub-contractors through performance monitoring system and QA audits to ensure desired quality and regulatory requirements are met
- Define regulatory pathway for the new product, new international territories.
- Manage CAPA system, ensuring system is fully compliant to regulations and fully utilised to ensure product non-conformance is reduced and quality system is improved
- Proactively search out continual quality improvement for the company quality management system
- Must have knowledge and proven track record / credentials in Regulatory Affairs management. (i.e. FDA, TGA) and ISO 13485.
- Medical device Quality and Regulatory experience.
- Must be experienced manager and leader, able to demonstrate excellent communication and interpersonal skills.
- Must have experience of manufacturing.
- Must have experience of dealing with process validation, sterilisation, reprocessing surgical instruments.
- Capable of handling a diverse range of projects simultaneously.
- Must have excellent I.T. skills to maintain various databases and present quality data in the form of departmental reports
- Degree qualified with an engineering, science or technology discipline
- Able to effectively communicate to a variety of audiences in an appropriate, meaningful and influential manner
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