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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)
- Solid 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 inc

📌 Staff Regulatory Affairs Specialist (Mississauga)
🏢 Becton Dickinson
📍 Mississauga