Regulatory Affairs Manager EU/Africa/Middle East (m/f)

REFERENZNUMMER:

255434/1

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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)

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager