Shreeya Patel is recruiting a Regulatory Affairs Specialist with proven experience of Medical Devices to join a leading supplier in their field at their site in Bedfordshire.
As Regulatory Affairs Specialist (Medical Devices) you will be providing regulatory support to the R&D project teams in order that the company can meet its delivery targets. You will be utilising detailed, in-depth and current understanding of global in vitro diagnostic medical device (IVD) and medical device regulations. The Regulatory Affairs Specialist (Medical Devices) will provide project and regulatory teams with timely input and guidance.
- The ability to independently and with minimal supervision, prepare complex regulatory documents for product clearance e.g. Technical File, 510(k) whilst clearly conveying project timelines, risks and opportunities.
- The maintaining of accurate records relating to interaction with Regulatory authorities
- The participation in design control and risk management activities as mandated in the site design control procedures, including review of clinical development plans, product evaluation protocols and other project documentation.
- The providing of effective technical/scientific input to the Marketing Design and Delivery teams, supporting claims development, substantiation, and the development and review of compliant promotional materials.
- The skill to review labelling, packaging and marketing tool kit components etc to ensure accuracy and compliance with government regulations.
- A minimum of BS degree or equivalent in a scientific field, plus relevant experience in IVD/Medical Device regulatory affairs.
- Sound IVD/Medical Device regulatory experience, including a successful track record in the registration and maintenance of products within Europe and the US.
- Practical experience of developing regulatory compliance strategies for medical devices containing hardware and software elements.
- Sound knowledge of relevant Quality Standards for medical devices and IVDs.
- Experience of substantial direct interaction with Competent Authorities and Notified Bodies.
For more information or to apply for the role please contact Shreeya Patel on 01438 743047 or email firstname.lastname@example.org.