Team Leader, Clinical Affairs

Vor 3 Tagen

Winterthur, Schweiz Zimmer Biomet Vollzeit

As a senior member of the clinical Post Market Surveillance Team, the Post Market Surveillance Team Leader will assume supervision role over a group of Post Market Surveillance Specialist team members ensuring timely and high quality in the execution of the tasks assigned to his/her direct reports.

The Post Market Surveillance Team Leader is still directly responsible for managing the typical activities of a Post Market Surveillance Specialist, such as: Document owner for Post Market Surveillance Activities; document PMSPs and if the case Review (PSURs or PMSRs) records according to the applicable regulations (including MDR (EU) 2017/745); responsible for working with Regulatory Affairs to ensure documentation has been reviewed and aligned with Notified Body (when applicable). Ensures Post Market Clinical Follow-up (PMCF) commitments are clearly documented within relative PMSPs, informed within clinical research department, and aligned with Notified Bodies. Scheduling and coordination of PMS teams for review of proactive and vigilance activities according to schedule; gathering inputs from cross functional stakeholders, and elevating at-risk findings to senior management. Track execution of PMS plans according to requirements; report to management on track, delayed and at risk PMS commitments; project management of PMS action items to ensure deadlines met. Completes routine audits of PMCF commitments against PMSPs to ensure quality and transparency of commitments is maintained.

**Principal Duties and Responsibilities**:

- Managing writing, reviewing and maintenance of post market surveillance (PMS) assignments; including document ownership of initial PMS plans (PMSPs), revised plans, tracking of Post Market Clinical Follow-up (PMCF) commitments and scheduling of PMS reviews (Periodic Safety Update Reports (PSURs) and/or Post market Surveillance Reports (PMSRs) as outputs) according to the PMS schedule.
- Identify pertinent internal and external sources of clinical data for the Zimmer Biomet products necessary to fulfill the regulatory requirements
- Support the Manager for Audit activities including the participation in Audits as clinical PMS SME as needed
- Supervise Post Market Surveillance Specialists in planning, coordinating and reviewing work assignments together with the Manager. In case of potential issues, recommends and acts upon appropriate solutions, in agreement with the Manager.
- Support the Manager for the definition of clear goals and objectives each year in line with Zimmer Biomet strategy and to help the team members in achieving career goals.
- Delivers results, drives for continuous improvement. Sets high performance expectations and holds him/herself and team members accountable for the results expected. Acts with a sense of urgency.
- Develop and maintain a team atmosphere.

**Education/Experience Requirements**:
**Education**:

- Minimum of a Bachelor’s degree or equivalent education in health, life sciences, engineering or a similar discipline required.
- Master and PhD degree preferred.

**Professional experience**:

- Medical Device Functional Experience (Clinical, Post Market Surveillance, Engineering, Regulatory, Quality or equivalent).
- Knowledge of Medical Device Directive and MDR (EU) 2017/745

**Special expertise**:

- Excellent written and verbal communications skills
- Knowledge of regulatory compliance for medical devices
- Demonstrated project management skills
- Strong ability to interpret and disseminate relevant product information
- Understanding of statistical methods
- Ability to critically analyze and interpret scientific data

**Personal skills requirements**:

- Have an analytic and strategic mindset
- Ability to work within tight deadlines, adjust to changes in priorities
- Ability to function independently
- Ability to identify problems and research possible solutions
- Possesses outstanding organizational skills, attention to detail and proofreading skills
- Takes actions that are best for the company versus his or her individual unit
- Encourages and supports information sharing and collaboration across teams and departments

**Languages**:

- English
- Knowledge of other foreign languages is a plus

**Travel Requirements**:

- 5%

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