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 makerof possible with us.
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About the role:
As the Staff Specialist, Regulatory Affairs, you will provide regulatory support to BD operations for market entry and maintenance of BD products including medical devices, drugs and natural health products. You will share your expertise and help train team members as well.
This is a 14-months contract role, hybrid 3 days onsite in our offices in Mississauga, ON.
Key responsibilities will include:
- Lead the management of regulatory activities involving compliance to government regulations and maintenance of establishment licenses
- Lead regulatory change management and drive major continuous improvement initiatives throughout the organization
- Classification and preparation of regulatory submissions, and effective negotiation of approvals for device and drug applications to Health Canada
- Perform regulatory activities such as new product activation, assessment of post-market changes, and Ad Promo reviews
- Provide guidance and interpretation of regulatory requirements to project teams, Business Leaders and other associates as needed
- Assist in the management of regulatory compliance activities including coordination of product recalls and support during audits and inspections
- Provide mentoring and training to team members through sharing of knowledge, advice and resources
- Assist with quality systems SOP maintenance, improvement activities and cross-functional training, and internal audits
- Assist with Health Canada inspections and corporate / third party audits
- Lead RA CAPAs stemming from internal / external audits
- Actively participate on regional and cross-functional teams
- Represent BD on external committees (e.g. Medtech Canada sub-committees) as required
About you:
To be successful in this role, you require
- Excellent verbal and written communication skills, as well as collaboration and teamwork skills.
- Flexible and adaptable with strong project / submissions management skills with the ability to prioritize and manage multiple deadlines.
- Strong regulatory strategy development
- Strong organization and time management skills to handle multiple activitie, with strong attention to details.
- 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.
- Ability to influence without authority to significantly impact engagement, cooperation, compliance and gathering of information to meet deadlines.
Education and experience required:
- Bachelor of Science degree in life sciences / engineering.
- Minimum 5 years regulatory affairs experience in the medical device industry.
- Expert professional knowledge of Canadian regulations for medical devices and drugs.
- Experience in preparation of medical device license applications and establishment license compliance.
- Strong proficiency with Adobe PDF, Microsoft (Word, Outlook), and Excel (VLOOKUP, Pivot Tables).
Education, experience, skills preferred:
- Advanced Science Degree preferred. Post-graduate certificate in Regulatory Affairs preferred.
- Regulatory Affairs experience with Canadian Medical Device products Class II through Class IV preferred.
- FDA PMA, 510k experience an asset.
- Experience with document management systems strongly preferred (Veeva).
- Pharmaceutical industry an asset.
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 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.
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. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization's investment in BD University, you will continually level up your tech skills and expertise.
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
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
Additional Locations
Work Shift