A vacancy has arisen for an experienced Regulatory Affairs Officer. Working within the healthcare divisions the successful candidate will be required to provide regulatory support across the full lifecycle of the products. This will include supporting the design, development, manufacture and post market surveillance of a range of medical devices. Key tasks will include the generation of technical files and design dossiers in support of CE marking and creation of submissions for other global competent authorities.
Working closely with the development team they will relay regulatory requirements in a clear and understandable way throughout the development process. Support for current products is also required to ensure Renishaw maintains compliance with EU Directive 93/42/EEC and the forthcoming MDR. On occasion, this will involve delivery of awareness training of relevant regulatory requirements to other team members. The role will also provide support to and may deputise for the Regulatory Affairs Manager as required.
• Give advice on regulatory issues to the development team
• Research and write submissions for Pre-Market Approval
• Provide regulatory support for clinical studies
• Input into PMS activities
• Support the Risk Management process
• Creation, implementation and maintenance of Regulatory procedures
• Working knowledge of MDD and new MDR and CE marking process
• 2-3 years’ experience in a medical device Regulatory position
• life science, engineering or medically-related degree.
• Working knowledge of EU, US and other Regulatory Pre-Market Submissions
• Experience in ISO 13485, ISO 14155 and ISO 14971
• Experience in 21CFR Part 820 Quality System Regulation (QSR)
• Excellent communication skills
• Experience of working with clinical trial applications
• Experience in custom made, neurological, dental or drug delivery devices
• Experience in MDSAP
• Knowledge of product development documentation for Medical Devices
• Expertise in Design Control to 13485:2003/21CFR part 820
• Familiarity in dealing with notified body visits
The successful applicant will be organised and self-motivated, with a good eye for detail yet able to be pragmatic. They will have a capacity for learning and will be able to absorb and subsequently implement new ideas. Capable of working both alone and especially as part of a team, the individual in this role will be in possession of excellent communication skills, both written and verbal and able to communicate clearly, in layman terms, to the team. They will be able to see the broad picture while maintaining a sharp focus on the short term, working to deadlines and dealing with several projects simultaneously. Finally, the ability to cope with pressured situations, and to be flexible in their working hours, is an essential requirement of this role.
When you join Renishaw, we're committing to your future career. That's because we believe in developing our peoples’ skills and promoting them internally. We also offer a benefits package that's highly desirable, including a 9% non-contributory pension, discretionary annual bonus and pay reviews, subsidised onsite restaurant, free parking and sports and leisure societies. Of course, we appreciate there’s more to work than the office, so we also offer 25 days holiday, Life Assurance and BUPA Renishaw Health Trust.