Merit Medical Systems
Senior Regulatory Specialist - Canada (French/English Bilingual Preferred)
Canada - Virtual, CA · Senior
Sponsorship not specifiedDetected 5 days ago
Project ManagementERPFDA RegulatoryMedical DevicesLeadershipCommunicationRegulatory Affairs
About the role
- Work Shift: DAY Work Schedule: Why Merit?
- 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.
Responsibilities
- Collaborate proactively with RA Platform teams to ensure regional requirements for product submissions are clearly understood and planned.
- 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.
- 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.
- Manage the regulatory license portfolio of responsible countries and align with commercial strategies.
- Leads integrated regulatory process and system improvement initiatives that will influence and build new capabilities for greater effectiveness and efficiencies.
- Support and suggest continuous improvement of resource planning within the team.
- Support Platform RA in conducting due diligence activities, as needed.
- Support the development and execution of RA strategies for integration of new acquisitions.
Requirements
- Work in conjunction with the QA PMS team to support and execute the reports required for field actions in responsible countries, with limited input and guidance from management.
- Performs other duties and tasks as required.
Benefits
- Participates in, supports, and creates Health Canada medical device regulatory submissions for specified products with limited input and guidance from peers and management.
Company info
- 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.
- To see more on our culture, go to www.merit.com/careers.
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This listing is sourced directly from Merit Medical Systems's careers page and normalized into a canonical job model.