Post Market Surveillance Senior Specialist - REMOTE

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Job Summary

Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

Position is responsible for post market surveillance (PMS) assignments; including document ownership of initial PMS plans, revised plans, tracking of Post Market Clinical Follow-up (PMCF) commitments and scheduling of PMS review according to the PMS schedule.

Principal Duties and Responsibilities

• Document owner for Post Market Surveillance Activities; Initial PMS Plans (PMSP) and Review (PMSR) records; responsible for working with Regulatory Affairs to ensure documentation has been reviewed and aligned with Notified Body (when applicable).
• Ensures Post Market Clinical Follow-up (PMCF) commitments are clearly documented within relative PMSPs, informed within clinical research department, and aligned with Notified Bodies
• Scheduling and coordination of PMS teams for review of proactive and vigilance activities according to schedule; gathering inputs from cross functional stakeholders, and elevating at-risk findings to senior management
• Track execution of PMS plan according to requirements; report to management on track, delayed and at risk PMS commitments; project management of PMS action items to ensure deadlines met
• Completes routine audits of PMCF commitments against PMSP to ensure quality and transparency of commitments is maintained.

Expected Areas of Competence

• Strong communication skills, both written and verbal; experienced intrapersonal skills and the ability to influence cross functional stakeholders and work in a fast paced environment prone to change. Strong attention to detail and ability to manage multiple projects and meet deadlines.
• Thorough knowledge of Global Medical Device regulations relative to Post Market Surveillance (Medical Device Directive & Revisions, ISO 14155, FDA Section 515 & 522, FDA MDR requirements, etc.) is preferred.
• Proficiency with Microsoft Office suite, and advanced spreadsheet or Microsoft Excel experience preferred.

Education/Experience Requirements

• 5+ Years of Medical Device Functional Experience (Clinical, Engineering, Regulatory or equivalent).
• Bachelors Degree required; Graduate Degree preferred.

Travel Requirements

Up to 10%

Additional Information

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.

EOE/M/F/Vet/Disability

Compensation Range: $89,000 - $107,000