QMS & Regulatory Affairs Manager - Italy
Consultant Marta Llagostera
Date posted 14 de octubre de 2016
Medical Device Company is hiring a QMS & Regulatory Affairs Manager for Italy. This company is dedicated to impacting the lives of people in a palliative way. The successful individual will ensure the appropriate licensing, marketing and legal compliance of the medical product, in order to control the safety and efficacy of the device
His/Her main functions will be:
- Ensure that the company product comply with the regulations of the EMA, FDA and MHRA.
- Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to.
- Collecting and evaluating scientific data that has been researched by colleagues.
- Negotiating with regulatory authorities for marketing authorisation.
- Reviewing company practices and providing advice on changes to systems.
- Advising scientists and manufacturers on regulatory requirements.
- Check and keep the revision of current legislation updated, as well as adequate all product expedients to it, analysing possible incidences and/or deviations.
You will need a Bachelor Degree in Life Sciences (Biochemistry, Biology, Biotechnology, Pharmacy, Chemistry). At least 3 years of experience in a similar position in Medical Devices Sector. Proficiency in English is essential. Availability to travel. It will be necessary: knowledge of European Regulation on Medical Devices and experience in acting as interlocutor with the public Health & Safety Agency.
If you believe you have the skills to take this role and be part of this amazing Regulatory Affairs challenge, please apply below.