Senior Regulatory Affairs Manager, Devices - Berkshire/Buckinghamshire
Star is looking for a Senior Regulatory Affairs Manager (devices) to join a market-leading device/pharma company. This role will focus on the company's class III medical devices across EU and global markets.
* The Senior Manager Regulatory Affairs plans and prepares 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, provides global project and regulatory teams with timely input and guidance
* Supports management with implementation of departmental strategies and policies
Education and Experience:
* A minimum of BS degree or equivalent in a scientific field, plus appropriate experience in regulatory affairs; the length of which is dependent on the level of qualifications achieved
* Sound Medical Device experience, including a successful track record in the registration and maintenance of products within Europe and other international markets
* Sound knowledge of relevant regulations and standards
* Direct interaction with competent authorities and Notified Bodies
* Must have experience with Class III medical devices
* Preferably have worked with 13485/14971/10993 etc.
Essential Skills and abilities:
* Excellent organisational/ planning and negotiation skills
* Excellent communication skills, both written and verbal (in English)
* Good interpersonal skills and the ability to influence others without formal authority
* Ability to work effectively and collaboratively across the global organisation and cross functionally
* Ability to coordinate and synchronise multiple projects and be flexible in changing daily workload priorities
To apply for this role, contact Will Evans on 01628 581 240 or apply through this website.
Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.