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Category : Medical Devices   |   Location : Geneva

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Regulatory Affairs Specialist (F/M)

Date : 2019-03-08 04:29:16

Our client, an FMCG-Life Sciences leading group based in Switzerland, is currently looking for their new Regulatory Affairs Specialist (F/M).

Responsibilities:
- Prepare and coordinate various activities to make applications for product licenses.
- Maintain an excellent understanding of global medical device regulations in accordance with ISO13485.
- Plan and prepare regulatory submissions for specific target markets for new products, product changes and re - registrations as required.
- Communicate with notified bodies and other regulatory authorities to ensure product approvals in a timely manner.
- Provide an effective follow-up during the registration process to ensure the completion of the product registration.
- Provide regulatory support to cross functional teams on site.
- Participate in working groups as part of continuous improvement of quality system.

Skills:
- 1-3 years of experience in a similar role, in regulatory affairs
- Knowledge of the requirements relative to the ISO13485, European directive 93/42 and 21 CFR part 820
- Good communication skills; Customer-orientated; Well-organised
- Fluent in French and English (Spanish is a plus)

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Approach People Recruitment was first established in 2000 and has, since then, become a leader in International Recruitment in Western Europe. We work closely with many of the World’s leading Multinational Companies to find their future talents.

We aim to offer highly professional advice to our candidates, taking into consideration their expectations and career goals. We try to constantly obtain new employment opportunities that match well our candidates’ skills and offer interesting career opportunities.



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