Work Shift:
DAY

Work Schedule:

ESSENTIAL FUNCTIONS PERFORMED

1. Exemplify an engaged culture that is tied to the Merit Way and the RA Manifesto.
2. Align with agreed regulatory strategies and timeframes, commercial priorities, and commercial revenue plans.
3. Collaborate proactively with RA Platform teams to ensure regional requirements for product submissions are clearly understood and planned.
4. Establishes working relationships with key stakeholders, especially RA and commercial platform team members, which enable constructive outcomes. Is a positive representative of the group in finding solutions that meet all needs.
5. Develop and implement effective communication and engagement strategies with partners.
6. Develop and maintain deep regulatory knowledge for responsible countries to ensure optimal regulatory strategies are used.
7. Participates in, supports, and creates Health Canada medical device regulatory submissions for specified products with limited input and guidance from peers and management.
8. Partner with the Commercial teams to prioritize and align product approval plans with commercial revenue plans.
9. Partner with the Platform RA team in the development, alignment and execution of Regulatory strategies for submissions in responsible countries.
10. For all submissions, uphold rigorous standards of accuracy, timeliness, compliance, and excellence.
11. 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.
12. Frequent interaction with regulators, with guidance from management. Represent Merit effectively and professionally.
13. Manage the regulatory license portfolio of responsible countries and align with commercial strategies.
14. Leads integrated regulatory process and system improvement initiatives that will influence and build new capabilities for greater effectiveness and efficiencies.
15. Support and suggest continuous improvement of resource planning within the team.
16. Ensure compliance with relevant regulatory requirements.
17. With limited input and guidance from management, support compliance with RA's Advocacy process by monitoring regulatory trends and changes across responsible countries to ensure Merit is proactively involved in shaping new regulations/guidance and guiding all stakeholders in anticipating, understanding and complying with new requirements.
18. Ensure the timely and accurate maintenance of regulatory data for responsible countries in applicable ERP, ship control, and RIM systems.
19. Support Platform RA in conducting due diligence activities, as needed. Support the development and execution of RA strategies for integration of new acquisitions.
20. Support and when needed represent Regulatory Affairs in audits/inspections in an effective and professional manner.
21. Assist in putting training material together at the direction of peers or management. Field complex questions as necessary. Help train other Specialists as directed.
22. Help develop and manage programs that train stakeholders on current and new regulatory requirements, systems, and tools to ensure organization-wide compliance.
23. Performs 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 Bachelor's degree in a technical field such as in the biological, physical, engineering, material science, regulatory, legal or related disciplines.
• 8+ years of Regulatory Submissions experience in the medical device industry.
• Deep and 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.

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.

To see more on our culture, go to www.merit.com/careers.