Regulatory Affairs Specialist

2 weeks ago

Mississauga, Canada BD Full time

**Job Description Summary**:
We are** the makers of possible**

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.

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’ll 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 standards
- Leading efforts for UDI including US, EU, and International requirements
- Support efforts for Technical File creation and remediation, collaborating with cross-functional teams for required content
- Support regulatory impact assessments for change controls and other RA/QA items
- Collect, 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 Regulations
- Assists in preparing, auditing, editing, and publishing registration documentation, as needed
- Support business export control (BEC) listing of product for release globally per RA requirements
- Support the review and approval of product labeling, promotional, and advertising materials as needed
- Performs other duties and assignments as required

**To be successful in this role, we require**:

- Strong organizational skills
- Strong prioritizing, interpersonal, communication, and analytical skills and the ability to multi-task disparate projects
- Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.) and work with all levels of management
- Read, analyze, and interpret regulatory literature and documents while effectively communicating information to peers and management while working independently with minimum supervision
- Identify and communicate risks and mitigations associated with global regulatory strategies to cross-functional collaborators

**Education and experience required**:

- A Bachelor’s degree, preferably Master’s degree in RA, QA, or life sciences
- Minimum 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 preferred
- Proficiency with MS office tools (Word, Excel, PowerPoint, Teams, Outlook) and Regulatory E-Systems.
- RAC certification preferred

**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.**

**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’s also a place where we help each other be great, we do what’s 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, you’ll 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.

Great Place to Work® has certified our workplace culture based on your feedback in the Trust Index® 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

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