Senior Regulatory Specialist
Location: NOORD BRABANT, NetherlandsThe Company
Being one of the most innovative companies in the healthcare industry with over 400 exciting and groundbreaking products designed to improve the quality of life of all of it's customers. Operating both B2B and B2C, their influences on the healthcare sector as a whole have been immense in it's 100+ years of operations.
Role Description
The Senior Regulatory Specialist provides strategic input during product creation process and supports in developing the department’s overall regulatory strategy plan. The Senior Regulatory Specialist cooperates closely with Product Development, Medical / Clinical Affairs and Marketing and Sales. We are looking for a regulatory affairs expert that has experience with submission of medical devices(FDA, Health Canada, EU, etc.)
Responsibilities
· Train regulatory resources in their development
· Exercise supervision in terms of schedules, methods and staffing for projects leading
· Key role in external and internal audits related to product submission such as FDA, MFDS, NMPA etc. and notified body audits
· Responsible for product registrations/approvals in her/his field
Requirements
· Minimal of 5 years of experience in the medical device industry
· Strong background in Design Controls
· Excellent working knowledge of Standards like IEC62304/82304/60601
· Excellent working knowledge of medical device regulations (21CFR), FDA Law, MDD, MDR, other global laws and regulations.
· Experience in supporting international registrations and clinical investigations(as a plus)
· RAPS certified(as a plus)
· Fluent in English, both verbal and in writing
For more information please contact Michaël Rodrigues at m.rodrigues@sire-search.com or +31 (0) 206589800 or click the button below
