BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Mississauga, Canada
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
About the role:
This position will provide regulatory support to BD operations for market entry and maintenance of BD products including medical devices, drugs and natural health products.
Key responsibilities will include:
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 BD on external committees (e.g. Medtech Canada sub-committees) as required
Assist with other BD business needs
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
Education and experience required:
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
Click on Apply if this sounds like you!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work Location
CAN Mississauga - Derry Road West
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.