Product Surveillance Specialist
Full Time
Indiana
$72,000 - $89,800 a year
Posted 1 day ago
Job description
Requisition Number
AMER27945
Employment Type
Full-time
Location
Other, Indiana
Job Summary
Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.
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.
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.
- Knowledge of EtQ, JD Edwards, Internet, Microsoft Office applications and the ability to learn other software quickly as required.
- 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
Up to 5%
Additional Information
At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.
EOE/M/W/Vet/Disability
Compensation range: $72,000 - $89,800
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.
EOE/M/W/Vet/Disability
Compensation range: $72,000 - $89,800
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