Senior Regulatory Specialist (Canada)

Work Shift

DAY

Work Schedule

Essential Functions Performed

• Exemplify an engaged culture that is tied to the Merit Way and the RA Manifesto.
• Align with agreed regulatory strategies and timeframes, commercial priorities, and commercial revenue plans.
• Collaborate proactively with RA Platform teams to ensure regional requirements for product submissions are clearly understood and planned.
• Establish working relationships with key stakeholders, especially RA and commercial platform team members, enabling constructive outcomes and representing the group positively in problem solving.
• Develop and implement effective communication and engagement strategies with partners.
• Develop and maintain deep regulatory knowledge for responsible countries to ensure optimal regulatory strategies are used.
• Participate in, support, and create regulatory submissions for specified products with limited input and guidance from peers and management.
• Partner with the Commercial teams to prioritize and align product approval plans with commercial revenue plans.
• Partner with the Platform RA team in the development, alignment and execution of Regulatory strategies for submissions in responsible countries.
• Uphold rigorous standards of accuracy, timeliness, compliance, and excellence for all submissions.
• Work in conjunction with the QA PMS team to support and execute reports required for field actions in responsible countries, with limited guidance from management.
• Engage with regulators, with guidance from management, representing Merit effectively and professionally.
• Manage the regulatory license portfolio of responsible countries and align with commercial strategies.
• Lead integrated regulatory process and system improvement initiatives that build new capabilities for greater effectiveness and efficiencies.
• Support and suggest continuous improvement of resource planning within the team.
• Ensure compliance with relevant regulatory requirements.
• Support compliance with RA’s Advocacy process by monitoring regulatory trends and changes across responsible countries, ensuring proactive engagement and guidance to stakeholders.
• Ensure timely and accurate maintenance of regulatory data for responsible countries in applicable ERP, ship control, and RIM systems.
• Support Platform RA in due diligence activities and in executing RA strategies for new acquisitions.
• Represent Regulatory Affairs in audits/inspections professionally and effectively.
• Assist in creating training material and field complex questions as necessary, helping train other Specialists as directed.
• Help develop and manage programs that train stakeholders on current and new regulatory requirements, systems, and tools organization‑wide.
• Perform other duties and tasks as required.

Essential Physical/Environmental Demands

• Lifting – Not to exceed 50 lbs – local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual acuity
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral

Summary of Minimum Qualifications

• Education and/or experience equivalent to a Bachelor’s degree in a technical field such as biology, physical sciences, engineering, materials science, regulatory, legal, or related disciplines.
• 8+ years of Regulatory Submissions experience in the medical device industry.
• Deep and demonstrated knowledge of applicable medical device regulations (Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, Design Controls).
• Ability to identify and frame concepts with a basic understanding of business impact.

Competencies

• Project management
• Written and verbal communication
• Attention to detail
• Continuous improvement
• Analytical skills
• Strategic leadership
• Team development
• Results‑oriented

Comments

Infectious Control Risk Category III: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs.

Risk category III states employment and procedures that do not require exposure.

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