Product Surveillance Analyst

hace 2 semanas

Bogota, Colombia Zimmer Biomet A tiempo completo

-Requisition Number
AMER28185
Employment Type
Full-time
Location
Bogota

**Job Summary**:

- 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 escalate high severity events and cases to Management and proposes solutions to day-to-day processing issues and enhancement opportunities**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.
- Supports and trains team members on complaint process.
- Supports audits and audit requests for complaints.
- Participates in complaint approval function. Assists Management in special projects as required.

**Expected Areas of Competence**:

- Strong organizational and time management skills.
- Strong written, oral, and presentation communication skills.
- Detail-oriented.
- Ability to consistently meet high standards of input accuracy, produce quality documents, compile data, and perform simple analyses with accuracy.
- Strong 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.

**Education/Experience Requirements**:

- Bachelor of Science degree in biology, health sciences, engineering, or nursing preferred or Bachelor’s degree in another discipline with equivalent years of relevant experience.

2+ years’ experience required, preferably in the medical device industry.
- **Travel Requirements**:

- 5%

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