Staff Regulatory Affairs Specialist in Mississauga

We are the people who give possibilities purpose. BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and 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.

This 21-month (approx) Staff Regulatory Affairs Specialist will provide regulatory support to BD operations for market entry and maintenance of BD products including medical devices and natural health products. This role is expected to share expertise and help train team members.

Job Responsibilities:

• 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.

Education and Experience:

• Minimum Bachelor of Science degree in life sciences / engineering (required); Advanced Science Degree (preferred).
• Post-graduate certificate in Regulatory Affairs (preferred).
• Minimum 7+ years of Regulatory Affairs experience within the medical device industry, including experience with Class III and Class IV medical devices.
• Expert knowledge of Canadian regulations for medical devices (required).
• Experience in preparation of medical device license applications and establishment license compliance (required).

Knowledge and Skills:

• Excellent verbal and written communication skills (required).
• Flexible and adaptable to fulfill business priorities (required).
• Excellent attention to details (required).
• Excellent collaboration and teamwork skills (required).
• Strong project / submissions management skills (Ability to prioritize and manage multiple deadlines) (required).
• Strong regulatory strategy development (required).
• Strong organization and time management skills to handle multiple activities (required).
• Results driven - can be counted on to achieve goals successfully (required).
• Continuous Versatile Learning - has the functional and technical knowledge and skills to do the job at a high level of accomplishment (required).
• Lead without authority (required).

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.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.

Salary Range Information: $85000 - $135000 CAD Annual.

This job posting is for an existing vacancy. As part of our recruitment process, we may, in certain circumstances, use technologies such as artificial intelligence or machine learning to screen, assess, or select applicants. These technologies will only be used in accordance with applicable laws and regulations.

Why Join Us? 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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

To learn more about BD visit https://bd.com/careers. Becton, Dickinson, and Company is an Equal Opportunity Employer.