Staff Regulatory Affairs Specialist (Contract Approx. 21 Months)

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 licensesLead regulatory change management and drive major continuous improvement initiatives throughout the organizationClassification and preparation of regulatory submissions, and effective negotiation of approvals for device and drug applications to Health CanadaPerform regulatory activities such as new product activation, assessment of post-market changes, and Ad Promo reviewsProvide guidance and interpretation of regulatory requirements to project teams, Business Leaders and other associates as neededAssist in the management of regulatory compliance activities including coordination of product recalls and support during audits and inspectionsProvide mentoring and training to team members through sharing of knowledge, advice and resourcesAssist with quality systems SOP maintenance, improvement activities and cross-functional training, and internal auditsAssist with Health Canada inspections and corporate / third party auditsLead RA CAPAs stemming from internal / external auditsActively participate on regional and cross-functional teamsRepresent BD on external committees (e.G. Medtech Canada sub committees) as requiredEducation 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 AnnualThis job posting is for an existing vacancy As part of our recruitment process, we may, in certain circumstances,usetechnologies such as artificial intelligence or machine learning to screen, assess, or select applicants. These technologies will only be used in accordance with applicable lawsand 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. To learn more about BD visit 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.Required Skills Optional Skills .Primary Work Location
CAN Mississauga - Derry Road West Additional Locations Work ShiftWe are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.
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