Senior Regulatory Affairs Specialist
CK QLS are recruiting for a Senior Regulatory Affairs Specialist to join a leading medical device company based at their site in Oberdorf on a contract basis until the end of 2021.
Senior Regulatory Affairs Specialist Role: The main purpose of the role will be to:
- Support MDR compliance execution work by creation/update Technical Documentation of existing devices to comply with MDR requirements.
- Identify, create, update, review and/or approve reference documents for technical documentation including, but not limited to design and risk documents, verification/validation documents, standards conformance, Clinical Evaluation Reports, General Safety and Performance (GSRP) Checklists, Instructions for use, labeling and Declaration of Conformity.
- Coordinate with various Technical file cross functional teams to make sure that data is aligned across the spectrum.
Further responsibilities will include:
- Identifying and adhering to policies, procedures and work instructions which support technical documentation activities.
- Supporting preparation of technical or design dossier documentation for submission to and review by Notified Bodies, as required.
- Working with cross-functional teams to obtain relevant informationand subsequent review of submission content as needed; assist in review of international product technical documents, marketing and labeling materials.
Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Regulatory experience in European Medical device industry. Proficient knowledge of MDR strongly preferred.
- Strong knowledge of ISO 13485.
- Understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745).
- Reasonable knowledge of FDA requirements and possibly registration requirements in further.
This is an excellent opportunity to join a global medical device company.
Apply: For more information or to apply for this Senior Regulatory Affairs Specialist position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email jblackham@ckqls.ch, quoting job ref 48709.
Please could you send any correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.
