Regulatory Affairs Specialist
Cardinal Health
Job Responsibility:
Cardinal Health Canada, with over 1300 Canadian employees nationwide, is an essential link in the Canadian healthcare supply chain, providing over 70,000 products to healthcare facilities and medical professionals across the country.
Cardinal Health Canada is currently seeking a Regulatory Affairs Specialist to join the Regulatory Affairs and Quality Assurance team. This position follows on-site Flex either in our Vaughan or our Mississauga location. The Regulatory Affairs Specialist will assist with planning, coordinating and implementing regulatory strategies for products that require government approval.
For more information on what it is like to work for us, please watch this video: Cardinal Health - Wings.
Your Contributions to the Organization will be to :
Prepare and file regulatory submissions to Health Canada including Class 2-4 medical device applications, Natural Health Product and cosmetic notifications.
Assess product classification for licensing strategy.
Prepare and file annual medical device license renewals.
Review Annual Summary Reports in accordance with Health Canada Medical Device Regulations
Assess changes to currently marketed medical devices for regulatory impacts in accordance with Canadian Medical Devices Regulations
Support regulatory queries from Health Canada
Prepare monthly regulatory metrics.
Maintains Regulatory information in the Digital Regulatory Information System
Monitor and report on new and updated Health Canada regulatory requirements.
Maintains all documentation in accordance with Good Manufacturing Practices requirements stipulated in the Food, Drugs Act and Canadian Medical Device Regulations
Assist with review and approval of advertising and promotional material.
Assists RAQA Department in the performance of tasks as deemed necessary.
Perform other administrative tasks as needed.
This Job might be for you if have:
Minimum Bachelor BSc degree required.
Minimum of 0-2 year(s) experience in Regulatory Affairs within the medical device or pharmaceutical or related industry.
Certification in regulatory affairs program preferred.
Applied knowledge of the Health Canada Food and Drug Act, Canadian Medical Devices Regulations, Drug Regulations and GMP, Natural Health Product Regulations, Cosmetics and Consumer Regulations.
Highly organized, problem solving, analytical and focused.
Proven communication skills (verbal, written and presentation skills) and computer literate.
Cardinal Health Canada is dedicated to the health and safety of its employees, customers and communities. Pursuant to this, we have implemented several COVID-19 safety measures, including a COVID-19 Vaccination Policy that requires all employees to be fully vaccinated. This is subject to reasonable accommodation for grounds protected under human rights legislation.
Cardinal Health is committed to employment equity and encourages applications from women, visible minorities, Indigenous people and persons with disabilities.
Cardinal Health is committed to accommodating applicants with disabilities throughout the hiring process, in accordance with the Accessibility for Ontarians with Disabilities Act (AODA). Our Human Resources team is responsible for working with applicants requesting an accommodation at any stage of the hiring process.
#LI-Hybrid
""Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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