Senior Regulatory Affairs Specialist – Medical Devices & IVD’s
Oxfordshire, UK – Office based
Up to £60, + benefits
This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose monitoring systems for use in both home and hospital settings.
With a diverse, global network serving customers in more than countries, the organisation creates new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, the business is advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The business currently hasoneopen positions as a Senior Regulatory Affairs Specialist who will be responsible for planning, creating, and implementing solutions for regulatory registration and release of products for distribution into specific geographies.
Key Responsibilities
·Lead processes and team involved with obtaining and maintaining product registration, release authorization, and release of products to specified geographies.
·Driving new registrations in the UK, EU, Middle East, and Pakistan regions.
·Drive regulatory strategies including working cross-functionally with other departments to ensure the right strategy is defined.
·Provide training and mentoring to junior colleagues with the scope to get into line management depending on the individual's preference.
·Interact with notified bodies and keep well-versed in global regulations.
Requirements
·University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering, or equivalent experience.
·Experience working within the requirements of ISO , the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC).
·Minimum of 4 to 5 years post-qualification experience in regulatory affairs, quality or R&D in the medical device and/or pharmaceutical industry in product registration, medical device file, and/or technical compliance activities.
Due to the organisation's rapid growth, there is extensive opportunity to grow and develop within the company. In addition to a competitive salary, the organsiation offers a highly attractive benefits package that includes a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme that you can tailor to your own requirements.
