Regulatory Affairs Specialist - Mississauga, Canada - Cardinal Health

Cardinal Health

Verified Company

Mississauga, Canada

3 weeks ago

Posted by:

Sophia Lee

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Description

Cardinal Health Canada, with over 1300 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 in Mississauga for a 14-month contract.

Regulatory Affairs plans, coordinates and implements regulatory strategies for products that require government approval. This role follows onsite flex model which requires onsite presence 2 days a week (Tuesday/Wednesday).

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_:

Evaluate and approve new products in our system as well as new suppliers and support Regulatory Affairs record management.
Support customer licensing process and holds related to drug orders.
Assess product classification upon item set up.
Evaluate changes of existing products and approve/or reject them when applicable.
Support maintenance of Drug Establishment License, Medical Device Establishment License, and Natural Health Product Site License.
Support regulatory queries from Health Canada, our customers, suppliers or any other department.
When necessary, assist in preparing and filing regulatory submissions to Health Canada related to Presource kits.
Support SAP process
Review and approve advertising and promotional material.
Maintains all documentation in accordance with Good Manufacturing Practices requirements stipulated in the Food, Drugs Act and Canadian Medical Device Regulations.
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:_

Bachelor's degree required.
Minimum of 13year(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 computer literate.

_ 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_
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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._