Senior Regulatory Affairs Specialist in Oberdorf
Senior Regulatory Affairs Specialist - Oberdorf
Jocelyn Blackham is recruiting for a Senior Regulatory Affairs Specialist to join a company in the Medical Device industry at their site based in Oberdord on a contract basis until the end of 2019.The main purpose of the role will be to support a New Product Development project. Responsibilities will include:
- Supporting preparation of technical documentation or design dossier documentation for submission to and review by Notified Bodies, as required (both MDD and MDR) as assigned.
- Provide regulatory support for Life Cycle Management projects as assigned.
- Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned.
- Perform Regulatory reviews for Labeling and Promotional Material of CE marked devices.
- Perform Regulatory Change assessments as assigned.
- Support compliance execution work in collaboration with local Regulatory Team.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- 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 Medical Device company is desired.
- 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.
This is an excellent opportunity to join a global Medical Device company.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 41 727 6793 or email jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 45278 in all correspondence.
