Senior Platform Regulatory Specialist

ESSENTIAL FUNCTIONS PERFORMED

1. Collaborates with key stakeholders to ensure alignment of regulatory goals and objectives with the strategic priorities of the business.

2. Develops and maintains strong strategic partnerships with project team members, including Marketing, R&D, Operations, Clinical Affairs and Quality Assurance.

3. Ensures all regulatory activities for assigned platform and operations projects comply with evolving global regulatory requirements.

4. Maintains product knowledge within the team and ensures essential data is gathered and organized in support of global submissions.

5. 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.

6. In collaboration with Regional RA, represents Merit effectively in interactions with Regulatory authorities, strengthening Merit's reputation and credibility.

7. Supports and suggests continuous improvement of regulatory processes, procedures and policies.

8. Ensures compliance with relevant regulatory requirements.

9. Ensures project teams are informed of new and pending changes in regulation and evolving interpretation of regulation and how they will be impacted.

10. Ensures the timely maintenance of regulatory data with a high degree of accuracy and compliance.

11. 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.

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