Regulatory Affairs Project Manager in Zuchwil
Regulatory Affairs Project Manager - Zuchwil
Jocelyn Blackham is recruiting for a Regulatory Affairs Project Manager to join a company in the Medical Device industry at their site based in Zuchwil. This position is offered on a contract basis until the end of 2019.
The main purpose of the role will be to:
- Support MDR compliance execution work by acting as project manager, overseeing the on ongoing MDR compliance work for the Trauma/CMF/BIO group and drive completion of MDR deliverables.
- Lead and track completion of MDR compliance activities for multiple given Technical documentation Files according to project plan.
- Lead regular status update meetings with corresponding teams who are working on individual MDR files.
- Provide regular status updates on MDR compliance progress for group to relevant teams.
- Facilitate resolving of roadblocks and timeline constraints for individual MDR files.
- Lead and track cross-functional activities as assigned, such as MDR IFU implementation and Technical Documentation submissions to Notified Body.
- Provide project management support for base business activities needed in preparation for MDR compliance as instructed and assigned.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Previous Project Management experience with preferably within Technical File remediation activities.
- Basic understanding of MDR requirements regarding required content of Technical Documentation.
- Basic understanding of current Council Directive 93/42/EEC.
- Previous experience with Notified Body interactions (e.g. renewals of Class III products) preferred.
- 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 leading Medical Device organisation.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 417276793 or email jblackham@ckqls.ch. Please quote reference QLS44044 in all correspondence.