3 X REGUlatory affairs managers

Vision Executives are looking for three Regulatory Affairs Managers to work with a leading opthalmic devices company. The candidates will be working with an international team of Regualtory Affairs Managers who will ensure the market availability of the company's products.
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These positions are based in either Germany or the country of expertise - USA, China, Japan and comes with a competative salary, bonus and social security.

The key responsibilities include:

• Responsibility for registration projects for non-active medical devices in ophthalmology - large focus on the market of the chosen country
• Prepare registration projects for non-active medical devices in the field of ophthalmology by analysing requirements from international regulations that are relevant for approval, examining and evaluating implementation options with relevant stakeholders and independently deriving approval strategies
• Planning, managing and controlling complex registration projects; implementing concepts and planned actions and ensuring approval
• Participate in international projects for new registrations, registration of product changes or changed requirements triggered by changes in regulations
• Participate in development projects and change committees on approval-relevant issues and specify normative and regulatory requirements
• Continuously analyse and optimise RA processes working together with, e.g. Quality Management, Global Regulatory Affairs, Clinical Affairs, in order to improve procedures or adapt them to new regulations

Suitable candidates will have a degree in a technical, economic or business subject and have knowledge of the regulations for medical devices with a focus on Japan/China/USA. They will also have several years experience in the field of regulatory affairs in medical technology. Knowledge of the regulations for medical devices with a focus on Europe and the US and related international standards is also required.

If applying for China/Japan positions, fluency in English and in Japanese/Chinese is a requirement. 

To apply for this position please email us, call us or submit you CV via our contact page quoting the vacancy reference: R2308RAM