
N/A
Director of Post Market Vigilance – Nationwide
1 year ago
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Post Market Vigilance assesses clinical customer experiences for the company’s global products and services and maintains regulatory compliance with regards to product complaints and the reporting of safety adverse events for all products manufactured or distributed by the company.
- Oversees department operations with supervision of managers and professional employees.
- Develops process strategies to improve efficiencies and achieve specific goals.
- Partners with functional leaders on strategic improvements and communication.
- Ensures complaint management practices are compliant with all applicable regulatory and quality requirements.
- Ensures employees operate within guidelines.
- Resolution of issues related to departmental operations and/or projects.
- Gains consensus through influence and persuasion while maintaining positive relationships.
- Establishes and delivers on goals specific to the quality compliance program for the company. Additionally, will deliver against annual objective to drive business growth through quality improvements.
- Participates in strategic planning for the quality organization.
- Communicates with both internal and external customers as well as regulatory authorities.
- Oversees a shared service provided to the business and required for compliance. There are times when this role will require negotiations and partnerships with other leaders within the organization.
- Follows established policies, procedures, and global regulatory requirements. Oversight, development, and improvement of specific functional policies and procedures.
- Some budgetary oversight (specific to supplies and headcount for this department only).
- 12+ years of experience preferred.
- Bachelor’s degree in related field, or equivalent work experience, preferred.
- Proven success as a positive change agent.
- Ability to effectively communicate and influence.
- Medical device industry experience highly preferred.
- Ability and willingness to travel 25% as needed.