Tandem Diabetes Care
San Diego, CA
You’ll be responsible for setting the strategic direction and implementing the Company’s global Complaint Management program. You’ll lead a team responsible for the timely and compliant submission of customer complaints to all applicable regulatory bodies.
Who we are:
Here at Tandem, Diabetes is all we do and we are dedicated to making the lives of people with diabetes better and better, through relentless innovation. ‘In Tandem’ means together, and we strive to embody that in every aspect of our business. We believe that working in tandem, not in isolation, is the best way to continually exceed expectations.
We’ve have been named one of the fastest growing insulin pump companies in the U.S! Why? Designed, assembled and supported from our San Diego, CA headquarters, Tandem has created the simple-to-use t:slim X2 Insulin Pump, which is the smallest pump available, the only color touch-screen insulin pump capable of remote feature updates, and the first CGM-enabled pump approved to let users make treatment decisions without pricking their finger.
Read more about our company & culture here: and see what our customers are saying here: #tsliminthewild
What you’ll be doing:
- Oversee a staff responsible for the management of company’s Complaint Management systems and processes.
- Responsible for the Company’s compliance with all required complaint standards worldwide, including compliance to FDA & OUS requirements.
- Act as the company’s representative for interactions and correspondence with FDA and OUS Competent Authorities on all matters related to complaints and Regulatory Reports.
- Communicate with the Sr. Leadership team regarding department metrics and trends; proactively identify areas of opportunity and implements solutions to address them.
- Responsible for compliance with regards to MDD, FDA, BSI, MDSAP, ISO 13485, Canadian requirements, OUS, etc.
- Identify and evaluate 3rd party vendors in order to optimize and streamline the complaint management process and systems.
- Work cross-functionally to enhance and optimize the use of existing technologies.
- Oversee the maintenance of all quality assurance databases specific to Complaints.
- Maintain and educate the Company on current knowledge of regulatory body and industry compliance standards related to complaint management and adverse event filings. Keep current on all standards and ensures standards are reviewed and updated with current standards continually.
- Ensure department staff is properly trained, per designated training plan, before assuming job responsibilities.
- Ensure compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
- Participate in the selection, development, performance appraisal, merit recommendation, and promotion of Complaint Management staff.
- Develop and manage schedules and performance requirements of the Complaint Management staff.
- Support the short and long-term planning for the department including headcount, budgeting, training, and systems requirements.
- Other responsibilities as assigned.
What you need for this position:
- Demonstrated experience creating and setting the strategic direction for an international Quality Complaints department.
- Proven leadership skills, team-building and mentoring skills, a track record of building, leading and working on teams, ability to coach both peers and subordinates effectively.
- Strong understanding of statistical techniques used to evaluate trending activities as related to Complaints and Regulatory Reports for all geographies.
- Thorough knowledge of current and pending FDA regulations, ISO 13485:2016, and OUS regulatory requirements/regulations, as business necessitates.
- Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to gain cooperation of others.
- Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals. Able to make and prioritize process and resource decisions based on overall team needs.
- Ability to communicate effectively both orally and in writing, to establish and maintain cooperative working relationships with persons inside and outside the business, and the ability to make effective and persuasive presentations both internally and externally.
- Demonstrated experience identifying and implementing process improvement initiatives.
- Ability to represent the Company and the department internally and at business functions in a competent and professional manner.
- Knowledge of lean processes or Six Sigma experience preferred.
Minimum certifications/educational level:
- Bachelor’s degree (B.A/B.S.) in related field or equivalent combination of education and applicable job experience.
- Master’s degree preferred.
- 15 years related experience in Medical Device industry.
- 5 years of experience leading an international quality complaints team.
- Experience conducting internal and external audits and hosting inspections by regulatory agencies and bodies.
What’s in it for you?
We’ve got you covered. We offer a robust benefits package to support your health and your family. From medical, dental, and vision, to flexible spending accounts for both health and dependent care – Tandem’s got you covered!
Stay well with us. Enjoy the outdoors during your workday by biking, running, or walking on one of our nearby trails. Or check out our offsite gym, which boasts luxurious amenities including specialty fitness classes and state-of-the-art equipment.
Invest in your career. Tandem offers all employees access to training and development programs and courses to help keep your career and skillset updated, not outdated.
Live your life. Relax with 20 days of paid time off and celebrate 10 paid holidays in your first year. Save for your future with a company-provided 401(k) plan. Look forward to saving money on tickets to the San Diego Zoo, movies, restaurants, and so much more with our exclusive employee discount program.
Celebrate in Tandem. Join in monthly employee get-togethers, tacos for Cinco de Mayo, corned beef for St. Patrick’s Day, costume-contest for Halloween, and the annual JDRF walk.
San Diego, California, United States