Product Surveillance Regional Leader

Job: Clinical/Regulatory

Primary Location: Europe-DE-BY-Putzbrunn

Travel%: 5%

Shift: Day

Schedule: Full-time

**Product Surveillance Regional Leader (f/m/d)**-231205

**About Us**:Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.

**About the Role**:We are looking for a Product Surveillance Regional Leader (f/m/d) to join our team. In this role, you will be responsible for providing direct leadership to the regional Product Surveillance Coordinators (f/m/d) and, in partnership with the Product Surveillance Leadership Team, ensuring adequate resources are in place and appropriately committed to comply with product surveillance event management and reporting requirements.

This position will be located at our facility in Putzbrunn, Bavaria, with work from home days possible as part of a hybrid arrangement, depending upon the responsibilities of the role and business needs.*

**Responsibilities**:

- Provide direct leadership to Product Surveillance Coordinators in the assigned region, including responsibility for performance and development (P&D) and contribution and compensation (C&C) processes
- In partnership with the Product Surveillance Leadership Team, develop vision, goals, and resourcing strategies for the Product Surveillance Group to support business and regulatory objectives
- Collaborate with the Product Surveillance Process Owner to ensure that the Product Surveillance Process is compliant with worldwide regulatory requirements, aligned with medical device industry standards and best practices and consistent across regions
- Monitor and communicate performance to metrics, including insight into trends, alerts, and actions, across product surveillance by participating in the Product Surveillance Trend Review Board Meeting(s) and holding Associates accountable to expectations
- Work closely with accountability partners such as Product Surveillance Process Owner, Product Surveillance Quality Assurance, Product Specialists, Clinical Application Complaint Specialists and Post-Market Surveillance (PMS) Regulatory to ensure cross functional success to execution
- Define and model the necessary functional disciplines to successfully execute the Product Surveillance strategies and objectives of the business
- Strong leadership skills, including the ability to provide constructive performance feedback with a collaborative style, to build positive relationships, and to improve business results through clarity and accountability
- Establish clear expectations of equitable and inclusive behaviors from Associates and act immediately to appropriately address negatively impactful or unfair behavior
- Develop talents and foster an inclusive and diverse workplace that enables all Associates to contribute to their full potential

**Required Qualifications**:

- Bachelor's degree in a scientific discipline, OR at least 6 years of healthcare or medical device industry work experience, OR Bachelor's degree in a non-scientific discipline AND at least 3 years of healthcare or medical device industry work experience
- Experience in leading diverse teams, coaching skills would be a plus
- Understanding of global regulations, standards, and industry terminology related to global post-market surveillance of medical devices
- Demonstrated experience supporting audits or regulatory response communications with successful results
- Flexibility and ability to prioritize and handle multiple tasks/projects
- Ability to team with multiple functional areas located across different physical locations
- Demonstrated experience in creating and maintaining an inclusive work environment with clear understanding of equitable practices
- Ability to problem solve independently, as well as part of a team
- Strong writing, communication, and organizational skills in English and German
- Competency in Microsoft Office

**Desired Qualifications**:

- Educational background and/or work experience in health care, medical coding, or a related field
- Experience developing and creating strong functional teams with robust talent pipeline
- Experience within Post-Market Surveillance software system SmartSolve
- Remote Working Arrangements are permitted for Associates, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed.

We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.

Our Talent Acquisition Team welcomes your questions at +49 (0)89 4612 2800 or toll-free at +800 4612 2800.

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