DJO, LLC is a global leader in technology-driven healthcare solutions for a complete continuum of patient care; injury prevention, surgical intervention, rehabilitation and pain management. DJO® employees enjoy challenging, highly rewarding careers in locations around the world and a culture that embraces talent, teamwork and innovation. Our medical technologies are designed to help get and keep people moving.
The Position: We’re looking for a Senior Manager, Regulatory Affairs in our Global Regulatory Department, at our Lewisville Texas location.
This leadership role supports the Global Product Registration Team, the regulatory registration strategy of DJO’s portfolio of products worldwide and contributes to global expansion business plans by assessing regulatory requirements in various international markets. The Global Product Registration Sr Manager will collaborate with the internal GPR Team as well as associates outside the US to manage the worldwide registration of products and will oversee the continued registration of marketed products on a worldwide basis. This role will be responsible for standardizing processes and procedures, implementing metrics and systems to streamline registration request completions, and ensure that the current DJO global product registrations are maintained.
- Establishes strategy and manages international registration activities for DJO’s targeted international markets
- Track registration status and provide timely updates to the management, update GPR metrics and reports
- Manage the Global Product Registration team made up of EMEA, ASIA-PAC, LATAM, ANZ, CAN regions and other countries/regions when needed.
- Provide regulatory support for new product registrations, renewals and product change registrations.
- Monitor, track and ensure all registrations are maintained and current, direct GPR Team members on upcoming registrations, provide metrics to management
- Communicate and interface directly with designated authorities and in-country distributors to ensure timely registration approvals.
- Ensures timely preparation by outside vendors, or the GPR team of requests for Certificates for Foreign Government, Certificates of Manufacturing and Free Sales, and Certificates for Exportability
- Monitors and compiles impact assessments of any product changes for outside the U.S and EU.
- Monitor the development of new regulatory requirements and advise of the impact.
- Support other GPR regulatory requests as needed.
- Evaluates proposed products for regulatory classification and jurisdiction
- Collaborate with team to assure high quality and successful completion of deliverables and identify risks and mitigation plans.
- Report on status, timelines and deliverables.
- Bachelor’s degree (science, engineering or medical) with a minimum of 5 years of medical device industry leadership experience and Global Product Registrations for medical devices
- Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing. High attention to detail and accuracy.
- Demonstrated proficiency in working in the international markets such as LATAM, ASIA-PAC, EMEA, UK, Canada, Australia/New Zealand, Middle East, etc.
- Ability to work with very little direction towards predetermined long-range goals and objectives. `
- Ability to achieve objectives and milestones through identification and implementation of work.
- Ability to identify and adapt to shifting priorities and competing demands
- Knowledge and understanding of global regulatory standards
- Proficiency in word processing tools, spreadsheets, and/or database applications (e.g., MS Word and Excel).
- Ability to work with all individuals in a congenial and cooperative manner.