Who We Are:
Therabody® is a pioneer in the wellness technology space, developing products and services that optimize human performance and unlock the body’s natural ability to achieve health and well-being. Founded by Dr. Jason Wersland to alleviate his own debilitating pain after a traumatic accident, he invented the category-defining percussive therapy device, Theragun®, which has been rooted in more than a decade of research and development.
The company continues to pave the way with its innovative ecosystem of wellness solutions, including pneumatic compression (RecoveryAir®), electrical stimulation (PowerDot®), vibration therapy (Wave series), and USDA Certified Organic CBD (TheraOne®).
Science is fundamental to Therabody’s DNA; Therabody uses existing science, combined with internal and external research, to validate products and services. Therabody’s products are embraced by both the medical community and millions of consumers worldwide. Currently available in more than 60 countries, including at company-owned retail stores and at Reset®, a whole-body wellness center.
Who We’re Looking for:
Therabody is seeking a highly motivated, quality-oriented Complaints & Post Market Surveillance Manager to join our growing Quality and Regulatory Compliance team. In this role, you will have significant responsibilities and will have the opportunity to work with Therabody’s senior management and across multiple business disciplines. This is a key position with a tremendous opportunity for career growth. This position reports to the Director, Quality and Regulatory Compliance.
- Bachelor’s Degree from an accredited institution in a scientific or engineering discipline. A Master’s Degree in a related field is a plus.
- 5 - 7 years of relevant work experience in the medical device industry in (a) quality-oriented role(s)
- Direct experience with receiving, evaluating, and investigating complaints
- Direct experience with submitting Adverse Event Reports to the US FDA
- Knowledge of European (EU) Vigilance Reporting
- Knowledge of Post Market Surveillance activities and requirements for the US and EU Markets
- Thorough understanding of 21CFR820, 822 803, and 806, ISO 13485, ISO 14971, EU MDR, & MDSAP
- Experience with Notified Body and Health Authority Inspections
- Experience with statistical methods of analyzing and reporting data is preferred
- Investigate, evaluate, and report product related complaints
- Submit timely Adverse Event Reports to the US FDA, when appropriate
- Manage EU Vigilance Reporting
- Conduct Post Market Surveillance activities to analyze post-market quality issues and trends
- Identify potential issues to continuously improve product safety
- Serve as the Subject Matter Expert to the Company for Complaints and Post Market Surveillance
- Support the continuous improvement of Therabody’s QMS
- Support Notified Body and Health Authority Inspections
- Perform other duties as assigned
- Up to 10% domestic travel is required
Locations: Los Angeles, Dallas, NYC. Remote considered.
Therabody is committed to diversity, equity and inclusion. We will not tolerate discrimination in employment, employment-related decisions, or in business dealings on the basis of race, color, genetic information, age, sex, sexual orientation, religion, disability, ethnicity, national origin, veteran status, marital status, pregnancy, or any other legally protected status. We will strive to provide an environment free of discrimination to our team members, customers, guests, and suppliers. We seek contributors from all backgrounds and walks of life to join our team, and we encourage our employees to bring their empowered, passionate, and authentic selves to work every day.