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.
- 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 firstname.lastname@example.org, 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.