Product Surveillance Manager (662672) at Zimmer Inc in Warsaw, Indiana

Job Description:

Job Summary

Zimmer Biomet is a world leader in musculoskeletal health solutions. 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 is responsible for developing and standardizing the requirements for processes. This position ensures that the processes are in compliance with applicable regulations and guidance requirements. This individual will stay current with changing regulations and guidance requirements worldwide and provide effective guidance and oversight to Zimmer Biomet locations as applicable. This role will interface with other areas of the Company and with varying levels of management.

Principal Duties and Responsibilities

Partners with Zimmer Biomet sites as applicable to ensure compliance across the enterprise. Ensures the Corporate processes are being followed. Ensures the continuous improvement of product quality and process improvements through the monitoring of post market product quality issues and trends. Ensures quality trend data is disseminated to the appropriate levels of the company for review and action if warranted. Ensures product safety issues are quickly identified, understood from a patient risk standpoint, and escalated appropriately to ensure proper action and/or agency notification is taken. Identifies and allocates resources, monitors resource requirements, escalates requirements to senior management as necessary.

Expected Areas of Competence

• Ability to work towards in-depth knowledge of Zimmer Biomet products, their medical application, and their manufacturing processes. • Ability to answer product-related questions from within the company, the field, and competent authorities worldwide. • Excellent problem solving skills. • Excellent project management skills. • Excellent written, oral, and presentation communication skills. • Detailed knowledge of regulatory authorities (domestic and international), guidance documents and standards. • Detailed knowledge of industry best practices for medical product complaint handling. • Ability to manage ongoing multiple tasks, be responsive to critical situations and changing priorities. • Ability to manage conflict. • Proficient knowledge of ISO 13485, Medical Device Directive, Canadian Medical Device Regulations, and/or FDA Quality Systems Regulations.

Education/Experience Requirements

• Bachelor’s degree required, preferably in biology, health sciences, engineering, or nursing or Bachelor’s degree in another discipline with equivalent years of relevant experience. • 6+ years’ work experience required, preferably in Regulatory Affairs, Regulatory Compliance, or a Post Market Surveillance area. • 3+ years’ of management experience preferred. • Project Management experience, or PMP certification is a plus.

Travel Requirements

Up to 20%

Additional Information

EOE/M/W/Vet/Disability 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.