Kelly Services Regulatory Affairs Associate - Medical Device in Toronto, Canada
Kelly Scientific Resources (KSR) is a specialty service of Kelly Services, Inc., a leader in providing workforce solutions. Since its launch in 1995, KSR has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical. Today, KSR leads the world in dedicated scientific and clinical research staffing. Visit www.kellyscientific.com to learn more and view a full listing of our opportunities.
REGULATORY AFFAIRS ASSOCIATE - MEDICAL DEVICE
A graduate degree in a science or health discipline or a graduate of a community college program in a related field with equivalent work experience.
Minimum 2 years of experience in a multi-division work environment within the healthcare industry.
Knowledge and application of national and international regulatory requirements for medical devices and drugs.
Knowledge and application of procedures, quality systems, and the ISO 13485 standard.
Superior analytical, organizational and independent problem-solving capabilities.
Computer literacy in Adobe Acrobat, Windows, Excel, MS Office.
Excellent verbal, composition and written communication skills.
Good interpersonal skills as this function interfaces with various departments as well as external customers, suppliers and Regulatory Authorities;
Assist the Director of Regulatory Affairs in the establishment of systems and databases to maintain compliance to national and international regulatory requirements;
Assist the Director of Regulatory Affairs with the coordination of submissions for new/existing product applications for regulatory compliance;
Support product label / packaging development.
Assist in maintaining practices that comply with the importation, testing, registration, and post-sale traceability and reporting requirements for 'Company' products;
Provide support to the R&D department in order to ensure compliance with 'Company' manufactured product. Compliance will encompass direction of regulatory registrations, product safety testing, and testing house audit reports & data files;
Provide guidance to the R&D, Quality and 'Company' manufacturing facilities with the appropriate GMP requirements, Standards & Guidelines applicable to the 'Company' production sites;
Act in a supportive role for the Business Unit and Sales regarding regulatory needs particularly to imported product for distribution purposes;
Assist in the monitoring of all incoming reports which may be of an "adverse incident" nature;
support audit / inspection