Description
A large multinational Medical Device Certification Body is now looking for a Global Medical Device Technical Manager to centrally manage the global medical device training process for both existing and new auditors to develop, update and maintain appropriate training packages for auditors, pack reviewers and other personnel involved in the medical device certification process.General Responsibilities;
- To provide expert regulatory advice to support all stages of the medical device certification process
- When necessary to undertake technical reviews and certification decisions of medical device assessment packs and to jointly manage the process with the Global Operations Manager
- To manage the development and implementation, including approval process for new regulatory schemes globally, ensuring effective integration and delivery (e.g. MDSAP, GD210)
- To contribute in the global management and business development as a member of the Global Medical Devices Management Team to achieve global revenue targets and maintain regulatory compliance.
- To plan and conduct professional management system audits in accordance with
- procedures to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards
- With the Global Operations manager to undertake reviews of packs and certification decisions and to manage the pack review process so that KPIs and approval criteria are met.
Essential Requirements;
- Good working knowledge of medical device management systems, standards, medical device compliance and auditing techniques
- Effective interpersonal skills, able to develop good working relationships with UK and affiliate colleagues
- Detailed understanding of global medical device regulations
- Management of cross functional global teams
- Expertise is sterilisation validation (irradiation and gamma peferred)
- Significant work experience in positions with significant RA/QA responsibility
- Significant medical device experience
- Significant auditing experience against recognised stsndards
- Experience working under own initiative and in planning and prioritising work
- Tertiary technical qualification ( degree, HND or equivalent)
- Medical device training ( product specific , ISO 14971 etc)
- Medical device lead auditor status (Desired).
This role would be home based, with 1-2 days in the south western office per week.My client is looking to pay very well for the right candidate so if you believe you have the required experience then please send me your CV and I will be in touch shortly.