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Job Details

Regulatory Affairs Specialist in Switzerland

Company: CK Clinical
Location: Switzerland
Reference: QLS44042
Closing Date: 26 Dec 18
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

Project name: MDR RA-Tech Files CK Group are recruiting for a Regulatory Affairs Specialist to support a local franchise Regulatory team for various activities in...

Requirements:

Project name: MDR RA-Tech Files

CK Group are recruiting for a Regulatory Affairs Specialist to support a local franchise Regulatory team for various activities in conjunction with MDR compliance work.

Job Profile:
- Support preparation of technical documentation or design dossier documentation for submission to and review by Notified Bodies, as required (both MDD and MDR).
- Provide regulatory support for New Project Development projects as assigned with focus on CE marking (under MDD as well as MDR) and US requirements (510(k)).
- Provide regulatory support for Life Cycle Management project as assigned.
- Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned.
- Perform Regulatory Change assessments as assigned,
- Perform Labeling and Promotional Material Reviews as assigned.

Your Background:
- At least 4 years of experience in Medical Device Industry and Regulatory Affairs.
- Understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745).
- Understanding of requirements of current Council Directive 93/42/EEC.
- Previous experience within Regulatory Affairs at DePuy Synthes preferred.
- Experience with creation and maintenance of Technical Documentation in PLM Systems preferred.
- Experience in IT system documentation and database management preferred.
- Experienced skills in MS Office (Excel, Access) for data analyses and comparisons.
- Ability to comprehend principles of engineering, physiology and medical device use.
- Strong analytical skills and proficiency in English written and spoken. German in addition, would be an asset.

Please quote reference QLS44042 in all correspondence.

Apply for this job: Regulatory Affairs Specialist in Switzerland

Contact Information:

Address:  Head Office
9 High Street
Stevenage
Hertfordshire
SG1 3BG
England
Tel:  +44 (0)1438 743047
Fax:  +44 (0) 1438723800
Website:  Visit Our Web Site

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