Merit Medical Systems
Platform Principal Regulatory Affairs Specialist
All US, USA · Principal
Sponsorship not specifiedDetected 5 days ago
Project ManagementFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationRegulatory Affairs
About the role
- Work Shift: DAY Work Schedule: Why Merit?
- In collaboration with Regional RA, represents Merit effectively in interactions with Regulatory authorities, strengthening Merit's reputation and credibility.
- Ensures project teams are informed of new and pending changes in regulation and evolving interpretation of regulation and how they will be impacted.
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.
- Maintains product knowledge within the team and ensures essential data is gathered and organized in support of global submissions.
- Supports and suggests continuous improvement of regulatory processes, procedures and policies.
- Supports Regulatory Affairs in due diligence activities to ensure regulatory risks and integration needs are clearly articulated and understood.
- Supports and when needed represents Regulatory Affairs in audits/inspections leading to successful outcomes.
Requirements
- As an eligible Merit employee, you can expect the following:
- Ensures the timely maintenance of regulatory data with a high degree of accuracy and compliance.
- Performs other duties and tasks as required.
Benefits
- Field of vision/peripheral
- Medical/Dental & Other Insurances (eligible the first of month after 30 days)
- 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
- 401K | Health Savings Account
- Low Cost Onsite Medical Clinic
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This listing is sourced directly from Merit Medical Systems's careers page and normalized into a canonical job model.