Regulatory Affairs Specialist
CK QLS are recruiting for a Regulatory Affairs Specialist to join a global medical device company at their site based in Zuchwil in the canton of Solothurn. This role is offered on a 12 month contract, with the possibility of extension.
The Company: This company is a global organisation, involved in the development and manufacture of products within the medical device, pharmaceutical and OTC industries.
Location: This Regulatory Affairs Specialist role will be based at our clients site in Zuchwil, Solothurn.
The Role: Responsibilities of the Regulatory Affairs Specialist:
- 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:
- 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.
- Experience with creation and maintenance of Technical Documentation in PLM Systems preferred.
- Strong analytical skills and proficiency in English written and spoken. German in addition, would be an asset.
Apply: For more information or to apply for this Regulatory Affairs Specialist position, please contact Jocelyn on 0041 (0) 782 516 595 or email jblackham@ckqls.ch, quoting job ref 48122.
Please send all of your correspondence in English.
It is essential that applicants hold entitlement to work in the country where the services will be delivered.
INDQLS
