Join BD as a Staff Regulatory Affairs Specialist for an approx. 21-month contract located in Mississauga, Canada. In this role, you will provide expert regulatory support for market entry and maintenance of medical devices, leading submissions to Health Canada and driving continuous improvement initiatives. The position requires a minimum of 4 days of in-office presence per week and offers a salary range of $85,000 - $135,000 CAD Annual.
Requirements
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 Class III and Class IV devices (required)
Expert knowledge of Canadian regulations for medical devices and establishment license compliance (required)
Strong project management, regulatory strategy development, and communication skills (required)
Skills & Responsibilities
Regulatory Strategy & Submissions: Lead the classification, preparation, and negotiation of device and drug applications with Health Canada to ensure market entry.
Compliance & Change Management: Manage regulatory activities, establishment licenses, post-market changes, and lead RA CAPAs stemming from internal and external audits.
Project Guidance & Training: Provide expert interpretation of regulatory requirements to project teams and mentor team members through knowledge sharing.
Audit & Recall Support: Assist in managing regulatory compliance activities, including product recalls and Health Canada inspections.
Potential transition routes: People from Quality Assurance, Clinical Affairs, or Compliance roles may bring regulatory knowledge and technical writing skills, alongside meeting the required medical device industry experience.
Job description
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’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.
Job Description
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 team work 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. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
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. You can learn more on our career site under "Your Career at BD”.
Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors that contribute to the range displayed. The range displayed is comprised of wages, which includes base salary and commission, as well as certain components of our bonus programs. The salary offered to a successful candidate may vary based on a variety of factors including relevant experience, education, skills, qualifications, and work location.
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.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
