Platform Principal Regulatory Affairs Specialist

Merit Medical Systems, Inc.•Utah - Virtual, UT

2d•Onsite

About The Position

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. This role collaborates with key stakeholders to ensure alignment of regulatory goals and objectives with the strategic priorities of the business. It develops and maintains strong strategic partnerships with project team members, including Marketing, R&D, Operations, Clinical Affairs and Quality Assurance. The specialist ensures all regulatory activities for assigned platform and operations projects comply with evolving global regulatory requirements, maintains product knowledge within the team, and ensures essential data is gathered and organized in support of global submissions. The role partners with the Regional RA team in the development, alignment and execution of Regulatory strategies for platform and operations projects and changes, upholding rigorous standards of accuracy, timeliness, compliance and excellence in regulatory strategy. In collaboration with Regional RA, represents Merit effectively in interactions with Regulatory authorities, strengthening Merit's reputation and credibility. Supports and suggests continuous improvement of regulatory processes, procedures and policies, and ensures compliance with relevant regulatory requirements. The specialist ensures project teams are informed of new and pending changes in regulation and evolving interpretation of regulation and how they will be impacted. Ensures the timely maintenance of regulatory data with a high degree of accuracy and compliance. Supports Regulatory Affairs in due diligence activities to ensure regulatory risks and integration needs are clearly articulated and understood. Coordinates with Regional RA on the integration of new acquisitions. Supports and when needed represents Regulatory Affairs in audits/inspections leading to successful outcomes. Performs other duties and tasks as required.

Requirements

Education and/or experience equivalent to Bachelor’s degree in a technical field such as in the biological, physical, engineering, material science, regulatory, legal or related disciplines.
15+ years of Regulatory Submissions experience in the medical device industry.
Considered an expert with demonstrated knowledge, use, and/or application of applicable medical device regulations (Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc., Design Controls).
Identify and frame concepts with a basic understanding of business impact.

Nice To Haves

Project management
Written and Verbal Communication
Attention to Detail
Continuous Improvement
Analytical Skills
Strategic leadership
Team development
Results oriented

Responsibilities

Collaborates with key stakeholders to ensure alignment of regulatory goals and objectives with the strategic priorities of the business.
Develops and maintains strong strategic partnerships with project team members, including Marketing, R&D, Operations, Clinical Affairs and Quality Assurance.
Ensures all regulatory activities for assigned platform and operations projects comply with evolving global regulatory requirements.
Maintains product knowledge within the team and ensures essential data is gathered and organized in support of global submissions.
Partners with the Regional RA team in the development, alignment and execution of Regulatory strategies for platform and operations projects and changes, upholding rigorous standards of accuracy, timeliness, compliance and excellence in regulatory strategy.
In collaboration with Regional RA, represents Merit effectively in interactions with Regulatory authorities, strengthening Merit's reputation and credibility.
Supports and suggests continuous improvement of regulatory processes, procedures and policies.
Ensures compliance with relevant regulatory requirements.
Ensures project teams are informed of new and pending changes in regulation and evolving interpretation of regulation and how they will be impacted.
Ensures the timely maintenance of regulatory data with a high degree of accuracy and compliance.
Supports Regulatory Affairs in due diligence activities to ensure regulatory risks and integration needs are clearly articulated and understood.
Coordinates with Regional RA on the integration of new acquisitions.
Supports and when needed represents Regulatory Affairs in audits/inspections leading to successful outcomes.
Performs other duties and tasks as required.