Description
We have an urgent project for a quality consultant to support deployment and implementation of projects defined under implementation of the new regulation for the medical devices.Major Responsibilities:
Collaborate with Regulatory department in order to collect the data from the dossiers in regards of the medical devices (for combination products)
Collaborate with internal stakeholders (Source QA & Make & Source) the follow up of original communication performed in regards of suppliers for medical devices
Follow up and collect the questionnaire sent out in relation with medical devices suppliers
Collect samples of the combination products and reports summary for the type of medical device
Perform a review of the questionnaires and consolidate an overview
Connect with other work stream in regards of the combination products list
Support the preparation of the regular updates within the organization
Collect from medical devices suppliers the documentation (as defined)
Support QMS workstream - review potential procedures which would need to be updated due to MDR implementation
Qualifications:
- BA degree in Life Sciences, Pharmacy or Engineering;
- General knowledge of global regulatory requirements (e.g. ISO 13485, 21 CFR Part 820);
- Excellent communication skills, verbal and written in English;
- Proficiency in MS office;
experience in a multinational environment in the MD / Med-tech industry. - Ability to multitask efficiently.
Please contact Beata Klecz on
Michael Bailey International is acting as an Employment Business in relation to this vacancy.