Platform Principal Regulatory Affairs Specialist

Essential Functions Performed

• 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.
• Safeguards all regulatory activities for assigned platform and operations projects to 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.
• Presents 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.

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.
• 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).
• Identifies and frames 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

Company Benefits

• Medical/Dental & Other Insurances (eligible the first of month after 30 days)
• Low Cost Onsite Medical Clinic
• Two (2) Onsite Cafeterias
• Employee Garden | Gardening Classes
• 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
• 401K | Health Savings Account