A fantastic opportunity for an experienced Medical Device Risk Management Specialist offering the flexibility of remote working (or site based if this is your preference)
- Remote Working
- 23 days holiday + bank (3 days reserved for Christmas shutdown), rising to 29 + bank with service
- Defined-contribution Pension Scheme - Company will match and double your contribution up to an employee contribution of 6% ( 6% employee +12% employer = 18% )
- Free Life Assurance
- Private Medical Insurance
- Free Annual Health Check with BUPA
- Access to a range of discounts and cash back offers
To manage risk-based activities during product development to ensure the inherent safety of the companies medical devices in use. Develop in-depth understanding of the use environment, clinical users, and procedures to guide project teams in the deployment of risk management processes. Support post market surveillance activities to maintain market safety and regulatory compliance.
- Provide technical subject matter guidance & training to others on Product Risk Management processes and techniques.
- Coordinate the Product Risk Management activities on projects and support the maintenance of project Risk Management Files.
- Review and remediate legacy product risk management files to ensure compliance to current risk management regulations/standards.
- Support Post Market Surveillance risk management activities to ensure continued adherence to standards as well as maintaining the safety and performance of devices on the market.
- Maintain internal risk management processes and procedures.
- Identify gaps in consistency of approach, application, understanding of the theme, and propose countermeasures and/or improvements.
- Maintain a strong and current understanding of the product risk management discipline and associated regulations/standards.
- Bachelors or master's degree in Engineering or equivalent professional or equivalent skill and knowledge gained through significant practical experience
- Educational qualification in a Risk Management related discipline
- Experience in a regulated and highly industrial or scientific engineering design environment
- Project Experience
- Experience and understanding of intellectual property
- Experience in medical device development (preferred)
- Applied knowledge and detailed understanding of Product Risk Management processes
- Proven experience of the tools and techniques required to apply Risk Management to products in development and post launch
- Understanding of current medical device Risk Management standards (i.e., BS EN ISO 14971, PD ISO/TR 24971, PD IEC/TE 80002-1, & BS EN IEC 60812
- Knowledge of FDA and MDR requirements for the application of Risk Management to medical device design is highly desirable
For immediate consideration please forward your most up to date CV
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.