Regulatory Affairs Manager

Regulatory Affairs Manager – Medical Devices

West Oxfordshire, UK – Office based

Up to £90,000 + 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 160 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 has one open position as Regulatory Affairs Manager 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.
• Authoring and updating technical files.
• Leading all activities related to class II and class III medical devices including SaMD.
• 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 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC).
• Minimum of 8 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.

This role is 100% on site, so you must be able to commit to this.

If you are interested in this role or would like more details, please email your CV lucy.kirkaldy@cpl.com