Product Surveillance Supervisor Emea

hace 3 semanas

Barcelona, España ZimVie A tiempo completo

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 Mission**:
Management and participation in EMEA Product Surveillance activities including the complaint receipt, processing and handling, reportability determination and vigilance report submission in conformance with US, European and other applicable international regulatory requirements. These activities include interactions with national competent authorities, direct customers, distributors, and ZimVie Subsidiaries to assure timely event assessment and reporting of reportable events.

**Main Functions**:

- Assure that all EMEA complaints are handled in the quality system in a timely manner
- If required, initiate and process complaint files
- Provide manufacturer incident reports to competent authorities and address any related regulatory inquires.
- Establish and maintain complaint procedures and practices in accordance with regulatory requirements for product complaint handling and vigilance reporting.
- Maintain a high level of medical device regulatory, dental implant and Spine industries knowledge through continuing education.
- Participate in internal and external departmental audits and responses to cited issues.
- Continuous improvement
- Promote a culture oriented to efficiency improvement and quality enhancement.
- Build and manage a multi-sector team based on organizational goals, budget considerations, and staffing needs.
- Monitor and assure compliance of the KPI’s and performs corrective and preventive actions, as necessary.
- Assure team members are fully trained (internally or externally) in the company SOPs, ZiimVie products and surgical procedures.
- Train other company team members and distributors regarding complaint notification, submission and product return.

**Profile**:

- Minimum of a Bachelor’s Degree in Healthcare, Scientific Sciences or Engineering
- Experience in medical devices and vigilance systems is required
- Several years of experience as a Team Lead
- Quality Assurance experience is preferred
- Excellent written and spoken communication skills in English. Additional European language is a plus
- Clinical degree or certification in the dental/medical field is a plus
- 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, etc. are considered without regard to racial or ethnic origin, gender, religion or belief, disability, age or sexual identity._

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