Primary responsibilities of the Regulatory Affairs Associate include preparing regulatory filings for products in portfolio to secure timely approvals and ensure ongoing compliance to Canadian Regulations, management of post-
approval changes and Regulatory Affairs support.
Essential Duties & Responsibilities
Reporting to the Canadian Regulatory Lead, the Regulatory Affairs Associate is responsible for the preparation of regulatory filings to Health Canada for products in the portfolio (DINA, NCs, S / NDS, NDS, Annual DIN Renewals, Annual Device License Renewals, Medical Device License Applications, and Medical Device License Amendments-
Responsible to maintain ICU Medical’s Regulatory databases
Assists in the development and maintenance of departmental processes, databases, SOPs and associated documents.
Assists in continuous improvement projects
Work on special projects as they arise
Knowledge, Skills & Qualifications
Excellent French & English written and oral communication skills is a requirement
Education and Experience
Typically requires travel less than 5% of the time
Physical Requirements and Work Environment
however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
CECI EST UN MANDAT TEMPORAIRE
Habilité à établir les priorités pour ce qui est des objectifs clés de l’entreprise et capacité à s’adapter rapidement aux changements de priorités