Product Surveillance Specialist
hace 2 días
Welcome to ZimVie, a new, publicly traded global company focused on improving quality of life for our patients. Our company is founded on a legacy of established brands, medical experts and over $1B in annual revenue. We design, manufacture, and distribute a comprehensive portfolio of innovative solutions for implant dentistry, spinal surgery and bone growth stimulation. Our seasoned leadership and dedicated global team of more than 2,500 is focused on shaping an exciting future for ZimVie — we hope you’ll consider being a part of it
**Job Title**:Product Surveillance Specialist
**Job Summary**:
This position is responsible for supporting the complaint handling unit by assessing complaints for Medical Device MDR / Vigilance reportability of adverse event(s) to the FDA and other National Competent Authorities in the countries in which ZimVie distributes products. This individual executes based on the adverse event determination process with a focus on the defined steps of this process. This position is responsible for decision-making, reassessment, preparation, and submission of adverse event reports globally, as required. Provides guidance and feedback to other team members pursuant to the defined procedures.. Responsible for follow-up with division personnel, site team, and international team members to ensure effectiveness and responsiveness related to the adverse event process. Responsible for the communication of data and escalation of potential high-risk complaints to the applicable to site manager and or process owner.
**Principal Duties and Responsibilities**:
- Adheres to all corporate and site-specific procedures.
- Identifies and investigates solutions to procedure and process-related issues. Revises the procedure or process as needed to increase efficiency and compliance.
- Documents and maintains complaint records in accordance with corporate and site-specific procedures.
- Creates, maintains and monitors appropriate metrics to measure the key performance indicators of the complaint unit.
- Evaluates and assess product complaints to determine adverse event reportability within the complaint-handling process.
- Accurately prepares, generates, and submits initial, supplemental, and final incident reports (e.g., MDR, MDR, etc.) within the regulatory timeframes.
- Provides direction to internal and external personnel on product experience reporting, complaint handling, and adverse event determination.
- Assists Management in special projects, as required.
- This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act._
**Expected Areas of Competence (i.e., knowledge, skills, and abilities)**:
- 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 to balance 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 the 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%
ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, demotion, evaluation, compensation, and separation, are considered without regard to race, color, national origin, ancestry, sex, sexual orientation, gender, gender identity, gender expression, transgender status, religion, religious beliefs, age, marital status, physical or mental disability, pregnancy status (including childbirth, lactation, breastfeeding or related medical conditions), parental status, genetic characteristics or information (including family medical history), political affiliation, military or veteran status or other classifications protected by applicable federal, state and local laws.
ZimVie generally does not sponsor applicant work visa
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