Regulatory Affairs Specialist
Responsibilities :
- Classification and preparation of Health Canada regulatory submissions for registration of medical devices, drugs and natural health products
- Life cycle maintenance of Product Licenses including but not limited to assessment of changes to determine Health Canada reporting pathway
- Assist in the management of regulatory compliance activities including coordination of product recalls, support during audits and inspections
- Assist in the management of regulatory activities involving compliance to government regulations and maintenance of product licenses, establishment licenses and quality system certificates
- Provide mentorship and interpretation of regulatory requirements to the business, and worldwide regulatory partners
- Proactively suggest improvements to submission management based on emerging submissions intelligence
- Represent Client on external committees (e.g. Medtech Canada sub-committees) as required
- Assist with other Client business needs
Requirements:
- Excellent verbal and written communication skills
- Flexible and adaptable to fulfill business priorities
- Excellent attention to details
- Excellent collaboration and partnership skills
- Strong project / submissions management skills (Ability to prioritize and manage multiple deadlines)
- Strong organization and time management skills to prioritize multiple activities
- Results driven- can be counted on to achieve goals successfully
- Continuous Versatile Learning - has the functional and technical knowledge and skills to do the job at a high level of accomplishment
- Willing to travel up to 10% of time and possess a valid passport
- Bachelor of Science degree in life sciences
- Post-graduate certificate in Regulatory Affairs preferred
- Minimum 2 - 5 years regulatory affairs experience in the medical device industry, pharmaceutical experience is an asset
- Solid understanding of Canadian regulations for medical devices and drugs
- Experience in preparation of medical device license applications