Specialist, Regulatory Affairs

at  Baxter

THIS IS WHERE YOU SAVE AND SUSTAIN LIVES

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

YOUR ROLE AT BAXTER

This role as a Regulatory Affairs Specialist involves preparing medical device submissions for Class 2-4 devices according to Health Canada requirements, collaborating with key stakeholders to provide accurate and timely responses, and assessing proposed changes according to Health Canada regulations. Additionally, the role includes developing regulatory project plans, compiling required documentation, providing guidance on labeling and promotional material, maintaining regulatory documents, establishing and improving local processes, and staying updated on current regulatory environment and guidelines. The role also involves participating in continuous improvement initiatives and maintaining positive relationships with internal and external business partners.

WHAT YOU’LL BE DOING

• Prepare medical device submissions for Class 2-4 devices (e.g. Applications for New Medical Device Licenses, Medical Device Licence amendments, etc.) according to current Health Canada requirements.
• Collaborate with key stakeholders to provide accurate and timely responses to Health Canada.
• Assess proposed product, process and manufacturing site changes according to Health Canada regulations and initiate necessary actions to facilitate implementation.
• Develop and/or review regulatory project plans/protocols and reports to meet Canadian regulatory requirements.
• Compile required documentation and evidence for Annual Medical Device Licence and Establishment Licence Renewals
• Provide guidance to Marketing, Medical Affairs and other business partners on initiation or modification of labeling and promotional material ensuring regulatory compliance.
• Organize and maintain regulatory documents in a format consistent with Baxter processes.
• Perform duties in compliance with standard operating procedures and quality system requirements.
• Establish and/or improve local processes by reviewing, providing input and/or drafting complex departmental/cross-functional SOPs and Global procedures.
• Maintain awareness of current regulatory environment and guidelines that impact the industry and Baxter. Analyze, interpret, assess impact, provide input into and compile comments for proposed regulations, guidance documents and policies.
• Participate in continuous improvement initiatives by actively participating on local and global cross-functional project teams ensuring milestones are met.
• Maintain close communication with both internal and external business partners and foster positive relationships.