Post Market Surveillance Sr Specialist

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patients mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect:

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.

Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)

How You'll Create Impact

• 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.

What Makes You Stand Out:

• 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.

Your Background

Required Skills

• Thorough knowledge of global medical device regulations related to post-market surveillance (Medical Device Directive and revisions, ISO 14155, FDA Sections 515 and 522, FDA MDR requirements, etc.) is preferred.
• Ability to think critically, manage projects, and analyze proactive data (not just reactive complaints).
• Excellent English oral and written communication skills.

Desired Skills:

• Direct experience with PSURs and PMS plans is preferred; however, candidates from adjacent areas such as product surveillance or complaints handling will also be considered, as this role may represent a natural step up.
• Prior experience with clinical trials is considered an asset.
• For junior positions, we welcome motivated candidates with experience in quality or product surveillance, giving priority to those who have shown a proactive approach to post-market surveillance (PMS).
• Strong project management and organizational skills.
• Proven ability to manage multiple projects concurrently while meeting strict deadlines.

Education and Experience Requirements:

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

Travel Expectations

• Less than 20%
• EOE/M/F/Vet/Disability