Clinical PMS Specialist: Flexible Post-Market Compliance

Zimmer Biomet; Bogotá ciudad; Presencial; COP 90.000.000 - 150.000.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

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

Educación

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

Master's degree

PhD degree

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

Descripción del empleo

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.