Clinical Post Market Surveillance Specialist

Zimmer Biomet; Bogotá ciudad; On-site; COP 90,000,000 - 150,000,000; Full time

Job summary

Zimmer Biomet is seeking a Clinical Post Market Surveillance Specialist to own PMS plans and PMCF commitments, coordinating reviews with regulatory affairs and cross-functional teams. You will track PMS actions, ensure timely PSURs/PMSRs, and support audits as a PMS SME, delivering quality and transparent commitments.

Among requirements are a health/science degree (Masters/PhD preferred), regulatory knowledge, and strong English communications. Travel up to 5% is possible.

Qualifications

• Bachelor’s degree or equivalent in health, life sciences, engineering or equivalent is required.
• Master and PhD degrees are preferred.
• Medical Device Functional Experience (Clinical, Post Market Surveillance, Engineering, Regulatory, Quality or equivalent).
• Knowledge of Medical Device Directive and MDR (EU) 2017/745.

Responsibilities

• Manage PMS assignments including PMS plans, PMCF commitments and PMS reviews.
• Coordinate PMS activities and meetings with cross-functional teams.
• Identify internal/external sources of clinical data for regulatory needs.
• Ensure PSUR/PMSR documents are created, reviewed and approved on time.
• Support audits as clinical PMS SME and drive continuous improvement.

Skills

Proficient in English

Excellent written communication

Regulatory compliance knowledge

Project management

Regulatory product information

Statistical methods

Data interpretation

Analytical mindset

Deadline orientation

Independent work

Problem solving

Attention to detail

Collaboration

Business ethics

Education

Bachelor's degree or equivalent in health, life sciences, engineering

Master's degree

PhD degree

Medical Device Experience (Clinical, PMS, Regulatory, Quality)

Job description

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 patient’s 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

The Clinical Post Market Surveillance Specialist is document owner for Post Market Surveillance Activities; will document PMS Plans and, if the case, PMS Reviews (PSURs or PMSRs) records according to the applicable regulations (including MDR (EU) 2017/745); he /she will be responsible for working with Regulatory Affairs to ensure documentation has been reviewed and aligned with Notified Body (when applicable). The Clinical PMS specialist will 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 Clinical 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 plans according to requirements; report to his / her manager 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 PMSPs to ensure quality and transparency of commitments is maintained.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

How You'll Create Impact

• Managing writing, reviewing and maintenance of post market surveillance (PMS) assignments; including document ownership of initial PMS plans (PMSPs), revised plans, tracking of Post Market Clinical Follow-up (PMCF) commitments and scheduling of PMS reviews (Periodic Safety Update Reports (PSURs) and/or Post market Surveillance Reports (PMSRs) as outputs) according to the PMS schedule.
• Identify pertinent internal and external sources of clinical data for the Zimmer Biomet products necessary to fulfill the regulatory requirements
• In collaboration with other team members as applicable and as needed, performs sales data searches and analysis, literature and registry reviews as well as complaints trending, similar devices in DAEN and HHEs on the products in scope.
• Organize and lead PMS review meetings
• Be accountable for getting PSUR / PMSR documents created, reviewed and approved in time as per plans
• Support the Manager or Team Leader for Audit activities including the participation in Audits as clinical PMS SME as needed
• Delivers results, drives for continuous improvement. Holds him/herself accountable for the results expected. Acts with a sense of urgency.

What Makes You Stand Out

Expected Areas Of Competence (i.e., Knowledge, Skills And Abilities)

• Proficient in English – written and spoken
• Excellent written and verbal communications skills
• Knowledge of regulatory compliance for medical devices
• Demonstrated project management skillsStrong ability to interpret and disseminate relevant product information for regulatory purposes
• Understanding of statistical methods
• Ability to critically analyze and interpret scientific data
• Have an analytic and strategic mindset
• Ability to work within tight deadlines, adjust to changes in priorities
• Ability to function independently
• Ability to identify problems and research possible solutions
• Possesses outstanding organizational skills, attention to detail and proofreading skills
• Takes actions that are best for the company versus his or her individual unit
• Encourages and supports information sharing and collaboration across teams and departments
• Demonstrates sound business ethics; shows consistency among principles, values and behaviors.

Your Background

Education/Experience Requirements

• Minimum of a Bachelor’s degree or equivalent education in health, life sciences, engineering or a similar discipline required.
• Master and PhD degree preferred.
• Medical Device Functional Experience (Clinical, Post Market Surveillance, Engineering, Regulatory, Quality or equivalent).
• Knowledge of Medical Device Directive and MDR (EU) 2017/745

Travel Expectations

• Up to 5%

EOE/M/F/Vet/Disability