senior regulatory affairs specialist in Solothurn

Randstad Professionals is currently looking for a Senior Regulatory Affairs Specialist in Medical Devices who will be assigned an interesting challenge for a major client based in Solothurn.

This contract is a great opportunity to join a major client, global group focusing on the Healthcare sector (Medical device, Pharma/vaccines, Consumer health).

The initial assignment will start ASAP ( december 2018) and will last until December 2019.

Your role will be to support local franchise Regulatory team for various activities in conjunction with MDR compliance work.

Tasks:

• 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

• Perform Regulatory Change assessments

• Perform Labeling and Promotional Material Reviews

Candidates’s profile :

• 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

• 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

• Proficiency in English written and spoken. German in addition, would be an asset.