Product Surveillance Specialist

hace 1 día


San José, San José, Costa Rica Zimvie A tiempo completo

Welcome to ZimVie, a pioneering global healthcare company dedicated to enhancing the quality of life for patients worldwide. Founded on a legacy of established medical brands and expertise, we have successfully integrated various business lines to create a comprehensive portfolio of innovative solutions for implant dentistry, spinal surgery, and bone growth stimulation.

We are shaping an exciting future at ZimVie, driven by our seasoned leadership team and a dedicated workforce of over 2,500 professionals. Our commitment to excellence is reflected in our rigorous adherence to regulatory standards and procedures.

**Job Summary:**

This role plays a pivotal part in our complaint handling unit, ensuring compliance with Medical Device MDR / Vigilance regulations. The incumbent will be responsible for assessing complaints and determining reportability of adverse events to national authorities, such as the FDA. Key duties include executing the adverse event determination process, decision-making, reassessment, preparation, and submission of reports globally, as required.

The successful candidate will provide guidance and feedback to colleagues, ensure timely follow-up with internal teams, and communicate data effectively. Additionally, they will escalate high-risk complaints to site managers or process owners, adhering to defined procedures and protocols.

**Key Responsibilities:**

1. Maintain accurate records of complaints and adverse events in accordance with corporate and site-specific guidelines.

2. Develop and monitor key performance indicators (KPIs) to measure the effectiveness of the complaint-handling process.

3. Evaluate product complaints to determine adverse event reportability within the complaint-handling process.

4. Prepare, generate, and submit incident reports (e.g., MDR) within regulatory timeframes.

5. Provide direction to internal and external personnel on product experience reporting, complaint handling, and adverse event determination.

**Requirements and Qualifications:**

To excel in this position, you will require:

Strong organizational and time management skills.

Excellent written, oral, and presentation communication skills.

Detailed-oriented approach to work.

Able to consistently meet high standards of accuracy, produce quality documents, and perform simple analyses with precision.

Effective decision-making skills, balancing priorities among ongoing tasks and critical situations.

Action-orientated mindset, able to take initiative to correct problems or make improvements without waiting for direction.

Proven ability to work in a team setting, share responsibilities, and participate in projects outside normal job scope.

Ability to provide training to team members as needed.

Willingness to work closely with others to ensure functional commitments are met.

Bachelor's degree in biology, health sciences, engineering, or nursing preferred. Alternatively, relevant experience in the medical device industry can be considered.

Travel requirements: up to 5%.

ZimVie values diversity and inclusion in the workplace. We strive to create an environment where all qualified applicants and employees can thrive, regardless of their background or characteristics. We do not discriminate based on race, color, national origin, ancestry, sex, sexual orientation, gender identity, religion, age, marital status, physical or mental disability, pregnancy status, parental status, genetic characteristics, political affiliation, military or veteran status, or other protected classifications.



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