Job Description

SummaryWe are the makers of possibleBD is one of the largest global medical technology companies in the world. Advancing the world of healthxe2x84xa2 is our Purpose, and itxe2x80x99s no small feat. It takes the imagination and passion of all of usxe2x80x94from design and engineering to the manufacturing and marketing of our billions of MedTech products per yearxe2x80x94to 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 youxe2x80x99ll be supported to learn, grow and become your best self. Become a maker of possible with us.As a Regulatory Affairs Specialist, you will assist in the analysis and improvement of existing regulatory processes through regulatory activity immersion.Primary Responsibilities: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 standardsLeading efforts for UDI including US, EU, and International requirementsSupport efforts for Technical File creation and remediation, collaborating with cross-functional teams for required contentSupport regulatory impact assessments for change controls and other RA/QA itemsCollect, 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 RegulationsAssists in preparing, auditing, editing, and publishing registration documentation, as neededSupport business export control (BEC) listing of product for release globally per RA requirementsSupport the review and approval of product labeling, promotional, and advertising materials as neededPerforms other duties and assignments as requiredTo be successful in this role, we require:Strong organizational skillsStrong prioritizing, interpersonal, communication, and analytical skills and the ability to multi-task disparate projectsAbility to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.) and work with all levels of managementRead, analyze, and interpret regulatory literature and documents while effectively communicating information to peers and management while working independently with minimum supervisionIdentify and communicate risks and mitigations associated with global regulatory strategies to cross-functional collaboratorsEducation and experience required:A Bachelorxe2x80x99s degree, preferably Masterxe2x80x99s degree in RA, QA, or life sciencesMinimum of 2 years of Regulatory Affairs experience in medical devices.Regulatory Affairs experience with Canadian and International regulations for Medical Device products Class I and II, EU MDR, UDI preferred.FDA PMA, 510k experience an asset.Knowledge of global Regulatory Affairs requirements and registrations.Regulatory and Quality Information Management systems such as SAP, RIM, or related systems experience preferredProficiency with MS office tools (Word, Excel, PowerPoint, Teams, Outlook) and Regulatory E-Systems.RAC certification preferredAt 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.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. Itxe2x80x99s also a place where we help each other be great, we do whatxe2x80x99s right, we hold each other accountable, and learn and improve every day.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, youxe2x80x99ll 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 visitGreat Place to Workxc2xae has certified our workplace culture based on your feedback in the Trust Indexxc2xae survey, and we've just published the news about us on their social media channels. You can check these out here. And if you think your friends and networks would be interested in knowing more about your workplace, sharing these posts is a great way to give them some insight!Becton Dickinson is an Equal Opportunity Employer. We encourage applications from individuals with a wide range of abilities and provide an accessible candidate experience. In accordance with the Accessibility for Ontarians with Disabilities Act, 2005, the Accessible British Columbia Act, 2021, and any other applicable legislation, including provincial human rights legislation, Becton Dickinson will provide reasonable accommodations to applicants with disabilities throughout the recruitment, selection, and/or assessment process. If selected to participate in the recruitment, selection, and/or assessment process, please inform us of any accommodation(s) you require by contacting HR at 1-855-234-3577.#earlycareerRequired SkillsOptional Skills.Primary Work Location CAN Mississauga - Derry Road WestAdditional LocationsWork Shift

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