Senior Manager, Regulatory Affairs, Medical Devices, Buckinghamshire, Berkshire, International, Europe
Your new company
Your new company market a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
They are focused on developing, manufacturing and commercialising branded pharmaceuticals, devices, biologics, surgical and regenerative medicine products for patients around the world.
Your new role
As Senior Manager of Regulatory Affairs, you will plan and prepare complex regulatory submission documents for regulatory filings for a range of medical devices in Europe; including CE marking and assisting with product registrations outside of the EU.
Utilising detailed, in-depth understanding of medical device regulations, and providing global project and regulatory teams with timely input and guidance. In the role of Senior Manager of Regulatory Affairs you will also support management with implementation of departmental strategies and policies.
What you'll need to succeed
As Senior Regulatory Affairs Manager you must have worked with Class III medical devices, and should have had experience of working with Notified Authorities and/or Competent Authorities. You will preferably have worked with 13485/14971/10993 etc. As Senior Manager of Regulatory Affairs you will be required to have excellent organisation, planning and negotiation skills, along with outstanding communication skills, both written and verbal (in English).
What you'll get in return
Highly competitive salary, excellent range of benefits such as a generous car allowance, healthcare and a pension scheme.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
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