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.

About the role:

As the Staff Specialist, Regulatory Affairs, you will assist in the analysis and improvement of existing regulatory processes through regulatory activity immersion.

This role is remote in Canada only.

Key responsibilities will include:

• Support regulatory efforts required to comply with new and existing regulations (e.g., FDA Medical Device Regulations and Guidelines, MDSAP) and other requirements including changes to FDA guidelines and applicable international standards
• Leading efforts for UDI including US, EU, and International requirements
• Support efforts for Technical File creation and remediation, collaborating with cross-functional teams for required content
• Support regulatory impact assessments for change controls and other RA/QA items
• Collect, store, and maintain regulatory documentation and assists in managing the data structure of the regulatory network (PIM, DMS, etc.)
• Proven ability to interpret medical device Quality System Regulations
• Assists in preparing, auditing, editing, and publishing registration documentation, as needed
• Support business export control (BEC) listing of product for release globally per RA requirements
• Support the review and approval of product labeling, promotional, and advertising materials as needed
• Performs other duties and assignments as required

About you:

To be successful in this role, you require

• Knowledge of global Regulatory Affairs requirements and registrations
• Strong organizational skills
• Strong prioritizing, interpersonal, communication, and analytical skills and the ability to multi-task disparate projects with keen attention to detail.
• Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.) and work with all levels of management
• Read, analyze, and interpret regulatory literature and documents while effectively communicating information to peers and management while working independently with minimum supervision
• Identify and communicate risks and mitigations associated with global regulatory strategies to cross-functional collaborators
• Excellent verbal and written communication skills, as well as collaboration and teamwork skills.
• 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 RA, QA, life sciences / engineering.
• 5 years regulatory affairs experience in the medical device industry.
• Professionnal knowledge of Canadian regulations for medical devices.
• 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).
• Experience with evaluating product design changes for regulatory impact.

Education, experience, skills preferred:

• Advanced Degree preferred. Post-graduate certificate in Regulatory Affairs.
• Regulatory Affairs experience with Canadian and International regulations for Medical Device products Class II and above strongly preferred.
• FDA PMA, 510k experience an asset.
• Experience with document management systems strongly preferred (Veeva).

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.

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