Product Surveillance Assoc Specialist

Zimmer Biomet; Bogotá ciudad; On-site; COP 90,000,000 - 130,000,000; Full time

Job summary

Zimmer Biomet seeks a detail‑oriented professional to manage medical device complaints for a designated unit. You will gather patient and product data, assess regulatory reporting requirements, and prepare submissions for authorities within set timeframes.

Strong English communication, regulatory awareness, and teamwork are essential. Prior experience in medical devices is a plus; international travel is possible up to 5%.

Qualifications

• Bachelor of Science in biology/health sciences/engineering or related field; nursing degree preferred.
• High proficiency in English (verbal and written).
• Co-op or intern experience in medical devices is a plus.

Responsibilities

• Manage complaint events for the designated unit and gather pertinent details.
• Assess events for regulatory reporting requirements and prepare reports for authorities.
• Submit regulatory reports within required timeframes and support metrics.

Skills

Attention to detail

English proficiency

Time management

Regulatory awareness

Education

Bachelor of Science in biology/health sciences/engineering

Nursing degree (preferred)

Tools

EtQ

JD Edwards

Microsoft Office

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

This position effectively manages complaints for the formally designated unit responsible for complaint management. This includes gathering pertinent details of the complaint event such as patient and product information. Assessing each complaint event for regulatory reporting requirements and creating regulatory reports for submission to FDA or Regional Competent Authority within regulatory timeframes. Closing investigated complaints within a timely manner. This role will also elevate high severity events and cases to Management and proposes solutions to day-to-day processing issues and enhancement opportunities.

How You'll Create Impact

Principal Duties and Responsibilities:

• Adheres to all corporate and site specific procedures.
• Documents and maintains records in accordance with corporate and site specific procedures.
• Gathers pertinent details of the complaint event.
• Assesses complaint events for regulatory reporting requirements.
• Submits regulatory reports to FDA or Regional Competent Authority within regulatory timeframes.
• Supports the completion of complaint activities in line with department metrics and key performance indicators.
• Assists Management in special projects as required.

What Makes You Stand Out

Expected Areas of Competence:

• Good organizational and time management skills.
• Good written, oral, and presentation communication skills.
• Knowledge of EtQ, JD Edwards, Internet, Microsoft Office applications and the ability to learn other software quickly as required, preferred.
• Detail-oriented.
• Ability to consistently meet high standards of input accuracy, produce quality documents, compile data, and perform simple analyses with accuracy.
• Good decision making skills and proven ability in balancing priorities among the many ongoing tasks, and being responsive to critical situations, as this position has a high volume of work, regulatory mandated time limits, and often changing priorities.
• Action-orientated: Ability to take initiative to correct problems or make changes for improvement without waiting for direction.
• Proven ability to work in a team setting. Willing to share the load and participate in projects outside of normal job scope. Ability to work closely with others to assure functional commitments is met.
• Proven ability to provide training to Team Members as needed.
• Ability to work with all individuals in a congenial and cooperative manner.

Your Background

• Bachelor of Science degree in biology, health sciences, engineering, or nursing preferred or Bachelor’s degree in another discipline with relevant experience.
• Communication skills: High proficiency in English (verbal and written)
• Co-op or Intern experience in medical devices, preferred.

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Physical Requirements

Travel Expectations

Up to 5%

EOE/M/F/Vet/Disability