Regulatory Affairs Specialist in Switzerland
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.
- 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.
- Previous 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.
For more information or to apply for this position, please contact Jocelyn Blackham at firstname.lastname@example.org. Please quote reference QLS44042 in all correspondence.