Regulatory affairs specialist
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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details
Company
Job Details
A thrilling opportunity has arisen for a Senior Regulatory Affairs Specialist to join a forward thinking Medical Device company who are pioneering in a broad range of therapy areas. Backed by top tier venture capitalists, this company are well funded and on track to grow by 50% in 2020. In 2019 alone, the company turned over €2.3 Billion in revenue - As a result, staff received a 17% annual bonus.As Senior Regulatory Affairs Specialist, you will work closely with the Regulatory Affairs Manager.
Your main mission is to manage a range of technical CE marking dossiers according to the standards and regulations in force. You are responsible for obtaining and maintaining the CE marking of the products that you you have to charge. You will have a tailored career development plan which is made to suit your interests/motivations.
Your main missions:
- You are responsible for obtaining the CE marking of your product range (preparation of dossiers
- CE marking techniques, development of the risk management file, monitoring of development projects ongoing, product modifications ...) and the renewal of EC certificates.
- You participate in the establishment of the regulatory strategy.
- You participate in the exchanges with the notified body.
- You are in charge of risk analyses for your product range.
- You are in charge of the post-market follow-up of your range of products and manage the impacts on the files techniques.
- You are in charge of the clinical evaluation reports for your product range.
- You participate in the management of International Regulatory Affairs.
- You also manage all the proofreading part of promotional materials by ensuring compliance with Regulations in force.
- You are in charge of the regulatory and normative watch and manage the impacts.
Otherwise:
- You contribute to the search for synergy with the quality department.
- You hold a scientific Master (biomedical engineer, quality engineer and / or business regulatory...) or a Master in Medical Device
- You have at least 3 to 5 years of experience in a similar position in a design structure and medical device manufacturing
- You know health organizations and are familiar with the European Directive 93/42 / EEC, ISO standards 9001 & 13485 and ISO 14971 with ideally class III product registration
- You have fluent English
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.Company info
Websitehttps://barringtonjames.com/
Telephone
01293 776644
Location
The Galleria
Station Road
Crawley
West Sussex
RH10 1WW
United Kingdom
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