Job Description

Summary



(1 year Remote Contract - Canada- Mississauga Derry Rd)

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health\xe2\x84\xa2 is our Purpose, and it\xe2\x80\x99s no small feat. It takes the creativity and passion of all of us\xe2\x80\x94from design and engineering to the manufacturing and marketing of our billions of MedTech products per year\xe2\x80\x94to 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 you\xe2\x80\x99ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Urology and Critical Care (UCC) is an established and trusted partner in urinary healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting. The Senior Regulatory Affairs Specialist is responsible for preparation of U.S and CE marking submissions/registration activities, with a primary focus on EU/MDR, along with supporting all other geographical regions registrations. In addition, this position will help support RA management with guidance and mentoring of department employees.

Key responsibilities will include:

Regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control, timeline development, and reviewing submission related documents).

Prepare STED technical files for CE marking activities and notified body interaction to accomplish EU/MDR product remediation, as required.

Provide support and guidance for post market activities including remedial actions, labeling and advertising and promotional material.

Prepare and support 510(k), IDE, PMA and Design Dossier submissions, as required.

Provide the appropriate information to support International product registrations.

May have direct supervisor responsibilities in addition to project team personnel; provides direction to assistant personnel.

To be successful in this role, you will work independently by applying your written and analytical skills to build technical documents, in some cases to cover design changes and change notifications for BD\xe2\x80\x99s wide range of medical devices. You will also demonstrate your communication skills to work effectively with internal customers and team members as well as external auditors.

Education and Experience required:

BS required, preferably in a Scientific Field or Regulated Industry

4 - 7 years experience in Regulatory (to include some experience within medical device); experience in areas of product registration, compliance or quality systems highly preferred

Regulatory Affairs Certification (RAC) desired.

Must demonstrate the ability to plan and complete regulatory pathway determinations, product registration submissions and other documentation.

Must be able to maintain confidentiality in dealing with regulatory and clinical documentation

Must be able to prioritize and handle several projects concurrently.

Must be self-motivated by working independently and having the ability to take ownership of their responsibilities.

Must be able to provide leadership and mentoring skills to less experienced regulatory personnel.

Must have knowledge of the U.S. and European medical device regulations.

Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience.

Limited travel required \xe2\x80\x93 15%.

For certain roles at BD, employment is contingent upon the Company\xe2\x80\x99s 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\xe2\x80\x99s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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. It\xe2\x80\x99s also a place where we help each other be great, we do what\xe2\x80\x99s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization\xe2\x80\x99s investment in BD University, you will continually level up your tech skills and expertise.

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, you\xe2\x80\x99ll 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 visit

Great Place to Work\xc2\xae has certified our workplace culture based on your feedback in the Trust Index\xc2\xae 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.

PDN

Primary Work Location CAN Mississauga - Derry Road West

Additional Locations

Work Shift

BD