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. Responsible for managing all facets of regulatory support to market Zimmer Biomet products. This includes development of regulatory strategies, submissions, reviewing labeling and promotional materials, providing guidance and consultation for regulations, interacting with APAC government authorities, participating in industry working groups, managing projects to support APAC registrations. Responsible for managing commercial quality and compliance projects and initiatives. An understanding of Zimmer Biomet products and their use as well as an understanding of the regulations and their application is required. This position focuses on subject matter expertise.

Principal Duties and Responsibilities

Work closely with Regional, Country, and Global teams to drive quality and regulatory projects/ initiatives. Drives APAC new registrations and supports registration maintenance:  Manages projects to communicate and implement regulatory strategies and plans. Support development of APAC positions on regulatory risk-benefit. Support APAC product positioning strategies based on regulatory requirements.  Communicates APAC requirements to internal stakeholders (provides strategic input and technical guidance on requirements to development teams).  Acts as a liaison with various functional, regional, and global teams.  Provides support in obtaining documentation for registration dossiers and responses to queries from the regulatory authorities.  Oversees tracking of projects on registration status and timelines.  Manages regulatory registration data to reduce registration cycle times through Speed to Market initiatives. Provides reports on registration status and cycle times.  Assists where necessary with reimbursements, tenders, government notifications, regulatory approvals, site certifications, quality field actions, PMS, audits/inspections, etc. 20 Understands and influences APAC medical device regulatory environment by leveraging key relationships with regulatory authorities and industry groups. Participates in working groups. Interprets and applies APAC regulations to business practices and provides regulatory input, advice, and guidance to the organization. Keeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products. 20 Responsible for Regulatory Compliance, which includes:  Participates in establishing Zimmer Biomet RA and Quality policies/procedures and ensures compliance to them.  Reviews advertising and promotional materials that are internally and publically disseminated for product claims. Ensures review by Country teams for compliance to local requirements. 10 Supports management of APAC Regulatory Affairs/QA budget. Responsible for oversight and prioritization of assigned projects. Supports the Country teams with training, mentoring, and professional development when needed.

Expected Areas of Competence

Strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory authorities  Competent English language skills (reading, writing, listening, and speaking)  Knowledge of medical device products and regulations and ability to interpret them  Ability to manage multiple projects, lead a team, influences others, and handles increasing levels of responsibility  Ability to build relationships with other areas of the organization (i.e. marketing, clinical)  Ability to identify and assess business risks to develop regulatory strategies  Responsible, professional, detail oriented  Strong computer skills

Education/Experience Requirements

Bachelor’s Degree in life sciences, technical (engineering), or related field; advanced degree strongly preferred  Minimum of 6 years of experience required in a Quality and/or Regulatory Affairs capacity  Experience in the areas of drugs, biologics, and combination products regulations is strongly preferred  A combination of education and experience may be considered  Project Management experience

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. Compensation Range: $110,000 - $131,000