regulatory affairs specialist à Zuchwil

publié
contact
Olivier Worch, Bâle Professionals Health Care & Life Sciences
type d'emploi
temporary
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job details

publié
lieu
zuchwil, soleure
secteur
Life Sciences
type d'emploi
temporary
référence
11617
contact
olivier worch, bâle professionals health care & life sciences
téléphone
058 201 55 50
postuler >

description du poste

Randstad Professionals is currently looking for a Reulatory Affair Specialist who will be assigned an interesting challenge for a major client based in Solothurn.   This contract is an unique opportunity to join a major client, global group focusing on the Healthcare sector  (Medical device, Pharma/vaccines, Consumer health).

The initial assignment will start immediately and will last until July 2020.

Job description:  Project specific support the internal Regulatory Affairs team in creation and maintenance of Technical Documentation for CE marked products (implants and instruments) according to Council Directive 92/42/EEC and Medical Device Regulation 2017/745.  These activities include but are not limited to:  - Creation of Technical File Summary Reports, Essential Requirements Checklists, General Safety and Performance Requirements Checklists, List of Applied Standards  - Reviewing of and providing input for Clinical Evaluation Reports, Risk Management, Labeling  - Creating and Maintaining of data sets that support Technical Documentation creation, maintenance and sustainability  - Support registration activities in G9 countries, EMEA, APAC, LAT and US  Requested Experience:   -Profound knowledge of European Medical Device Regulations,especially Council Directive 93/42/EEC and Medical Device Regulation 2017/745  - 2-3 years of experience in European Medical device Industry especially within regulatory, labeling, quality or engineering.  -Familiarity with Technical Documentation structure according to STED and as required by Medical Device Regulation 2017/745  - experience with PLM systems such as Windchill PLM, Agile e6 PLM, preferred  - Technically versed in computer software such as MS Word, Powerpoint.  - Strong skills in MS Excel essential  - Strong database skills (Access, SQL) desired  - Strong analyticalskills and network thinking  - English spoken and written, German in addition would be desired

If you are interested for this great role, don't hesitate to send your application or to contact me directly. I am looking forward to sharing details about this assignment with you. 

Olivier Worch Consultant Life Sciences T +41 58 201 55 55 olivier.worch@ch.randstad.com