Quality Assurance and Regulatory Affairs Specialis
Quality Assurance and Regulatory Affairs Specialist - Zug
Jasmin Baumgartner is recruiting for Quality Assurance and Regulatory Affairs Specialist to join a Medical Device company in at their site in Zug on a six month contract.
The main purpose of the role will be to:
Work in collaboration with the Regulatory team in order to gather the data from the dossiers in regards of the medical devices for combination products.
Coordinate the questionnaire sent out in relation with medical devices suppliers.
Work in partnership with internal stakeholders, the follow up of original communication made internal and external teams in regards of suppliers for medical devices.
Further responsibilities will include:
Linking with UDI work stream in regards of the combination products list, to check sale forecast.
Building the logistic flow for all impacted products under MDR.
Collection of samples of the combination products from external manufacturers and join the overview in regards of the artwork information and type of medical device used versus dossier.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
BA degree in Life Sciences, Pharmacy or Engineering.
Experienced in a multinational setting in the Medical Device/ Med-tech industry.
Understanding of global regulatory requirements (such as ISO 13485, 21 CFR Part 820).
This is an excellent opportunity to join a leading medical device organisation.
For more information or to apply for this position, please contact Jasmin Baumgartner on 0041 (0) 782 516 595 or email jbaumgartner@ckqls.ch. Please quote reference 44762 in all correspondence.
