Faites partie de quelque chose de plus grand chez BD. Ici, vous nous aiderez à maintenir nos normes élevées d'un point de vue réglementaire à tous les niveaux, avec un accent particulier sur les soumissions. Cela exige une attention aiguë aux détails, d'excellentes compétences en communication et une passion pour continuer à apprendre et à mettre à jour vos connaissances, ce que nous vous aiderons à faire avec des opportunités d'apprentissage régulières. Ici, vous utiliserez vos connaissances approfondies des réglementations et des exigences de la FDA, du Canada et de l'ISO/MDD entourant les dispositifs médicaux pour atteindre finalement un objectif unique : faire progresser le monde de la santé™. Chez BD, vous pouvez faire une véritable différence d'une personne.
Responsibilities
Job Description Summary
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
DESCRIPTION
JOB SUMMARY:
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.
DUTIES & RESPONSIBILITIES:
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
Proactively suggest improvements to submission management based on emerging submissions intelligence
Assist with other BD business needs
QUALIFICATIONS
ABILITIES:
Excellent verbal and written communication skills
Flexible and adaptable to fulfill business priorities
Excellent attention to details
Excellent collaboration and team work skills
Strong organization and time management skills to handle 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
KNOWLEDGE & SKILLS:
University degree in life sciences; Advanced degree preferred
Post-graduate certificate in Regulatory Affairs strongly preferred
Regulatory affairs experience in the medical device industry, pharmaceutical experience is strongly preferred
Strong knowledge of Canadian regulations for medical devices and drugs
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Great Place to Work® has certified our workplace culture based on your feedback in the Trust Index® survey, and we've just published the news about us on their social media channels. You can check these out here. And if you think your friends and networks would be interested in knowing more about your workplace, sharing these posts is a great way to give them some insight!
Becton Dickinson is an Equal Opportunity Employer. We encourage applications from individuals with a wide range of abilities and provide an accessible candidate experience. In accordance with the Accessibility for Ontarians with Disabilities Act, 2005, the Accessible British Columbia Act, 2021, and any other applicable legislation, including provincial human rights legislation, Becton Dickinson will provide reasonable accommodations to applicants with disabilities throughout the recruitment, selection, and/or assessment process. If selected to participate in the recruitment, selection, and/or assessment process, please inform us of any accommodation(s) you require by contacting HR at 1-855-234-3577.
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Required Skills
Optional Skills
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Primary Work Location
CAN Mississauga - Derry Road WestAdditional Locations
Work Shift
Success Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter
Advancing the world of health™
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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.