Description
We are looking for a
Regulatory Affairs Manager EU/Africa/Middle East (m/f)
Reference: -en
Start: 02/15
Duration: 12 MM++
Place: in Baden-Württemberg
Branch: Großhandel mit medizinischen und orthopädischen Artikeln, Dental- und Laborbedarf
Your tasks:
- Prepare, assemble and submit regulatory submissions for achieving registrations of IOLs&IOL accessories in EMEA
- Carry out CE submissions and change submissions for the IOL&IOL accessory products at our Notified Body
- Review of Technical Files, Technical documentation and labelling for Regulatory compliance prior to submission to Notified Body
- Provide RA support to achieve local registrations and market authorizations in the EMEA region and also supporting other regional RA departments which rely on the European registrations
- Global Regulatory impact assessments for all changes at the manufacturing site
- Responsibility for Regulatory distribution release for the IOL&IOL accessory products
- Support labelling & packaging compliance to ensure that labelling/packaging of all new and existing IOLs&IOL accessories is in line with MDD requirements and national EMEA regulations
- Supporting the Regulatory Affairs part of Notified Body audits
Your qualifications
- University degree in life sciences or medical device engineering (e.g. chemistry, biology, pharmacy, medical or optical engineer) or a long-term healthcare industry background is required
- Regulatory knowledge especially in European medical device regulation or European advertisement regulations is highly appreciated
- Experience with contact lens care products, eye surgical products or pharmaceuticals (knowledge of products and market) is of advantage
- Good English and German skills (spoken and written)
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager