GROW WITH US:
Headquartered in San Diego with customers all over the world, Tandem Diabetes Care is 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. Our offices are centrally located north of Downtown with easy access to the freeway.
A DAY IN THE LIFE:
The Sr. Vice President, Quality and Regulatory is responsible for overseeing the development, planning and execution of the Company’s worldwide Quality and Regulatory strategies for Tandem’s innovative hardware and software products and related services across domestic and international markets. They will provide expertise and guidance in interpreting government regulations, agency guidelines, and internal policies to assure compliance with global standards. Additionally, they serve as the top representative in the quality and regulatory departments for both internal and external functions by directing assessment and improvement of key business processes to ensure compliance with current and future regulations set forth by the US FDA and equivalent international bodies.
Provides vision and leadership in the development of the quality and regulatory departments and may represent the Company externally in discussions with regulatory authorities worldwide with emphasis on US, Europe, Canada and Australia/New Zealand. Creates quality and regulatory strategies, systems and processes to ensure that development, registration and commercialization plans meet all federal, foreign, and company requirements to enable the effective advancement of hardware and digital health products from design concept through marketing and post market surveillance. Provides strategic direction and guidance to the Senior Leadership Team regarding Quality timelines for new and revised products, processes, and regulations & guidances. Fosters a culture of No Shortcuts, professional integrity and respect for customer safety, ensuring that all necessary management systems are in place to make these high principles actionable and assure compliant practices that will result in the Company’s ultimate medical and commercial success. Provides strategic consultation and guidance to external and internal subject matter experts with regards to go/no-go development decision criteria on significant quality and regulatory components and implications. Participates in defining and developing broad strategies consistent with business objectives and regulatory requirements. Ensures that New Product Development teams have appropriate quality and regulatory representation for all key development programs. Provides quality and regulatory oversight of any contract manufacturing organizations supporting Tandem Diabetes Care. Supports the development of strategic and tactical plans for all regulatory submissions including all US and OUS filings, ensures completeness, administrative and scientific accuracy; facilitates timely government approvals for marketing new and modified products. Represents Tandem by acting as a liaison between external collaborators and internal stakeholders. Supports post-market surveillance activities related to product complaint handling, and Adverse Event Reporting. Oversees internal and external audits to ensure compliance with all quality standards. Responsible for initiating corrective actions and driving root cause analysis and resolution of issues through team members and suppliers as necessary. Partners with Medical Affairs, R&D, Legal, Operations, and other appropriate department leaders in overseeing entire product realization efforts to ensure integrity and quality of data. Provides insight into the potential quality and regulatory risks and benefits of business plans, including directing alternative action plans based on risk/benefit analyses. Directs long and short-term planning for the department including headcount, budgeting, training, and systems requirements. Partners with Operations to support cost reduction initiatives. Participates as a partner with suppliers, involved in supplier selection and overall monitoring of the approved suppliers. Participates as a member of the Senior Leadership Team in defining the strategy, direction and vision of the organization. Interfaces directly with Board of Directors and agencies regarding regulatory matters. May be requested to speak or act on behalf of the Company including but not limited to publicly representing the Company’s thoughts or position on a subject, or publicly sharing new information about the Company, its products, processes, technology or partnerships. May be requested to speak to health care providers and/or customers as the voice of Tandem. Interface with Tandem partners to develop practices and procedures that benefit joint customers. Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
WHAT YOU’LL NEED :
Bachelor’s degree (B.A/B.S.) in related field or combination of equivalent education and applicable work experience. 15 plus years related experience or equivalent in medical device or related industry. 10 plus years’ experience in a senior management role in a commercial stage company with global operations. Proven success overseeing complex regulatory submissions and quality initiatives for global enterprise. Experience implementing and overseeing systems and processes needed for EU Medical Device Regulations for medical device hardware and software. Strong knowledge and understanding of the job to oversee the quality and regulatory functions of a medical device company operating globally. Experience with regulatory strategies for medical device hardware and software, including digital health initiatives for users, caregivers, healthcare providers and other constituents. Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals. Ability to proactively identify areas for further investment or improvement, recommend and see solutions through to completion. Ability to communicate at all levels of the organization including with Board of Directors, investors and other third parties. Ability to establish credibility, trust and strong working relationships both inside and outside the Company. Excellent analytical, management, and organizational skills. Experienced with MS Office and HR system tools. Advanced degree strongly preferred.
WHAT’S IN IT FOR YOU?
At Tandem, our employees are just as important as our customers! Not only do we hire the best, we reward, develop, and retain them too. At Tandem we offer competitive compensation packages, superb medical, dental and vision, a discounted stock purchasing plan, fitness discounts, generous PTO, casual work attire and more! For a full list of benefits please review our perks page at https://www.tandemdiabetes.com/careers/benefits .
DIABETES IS ALL WE DO:
At Tandem, Diabetes is all we do. We are the makers of the only color, touch-screen insulin pump that is capable of remote feature updates and compatibility with continuous glucose monitoring. Read more about our company and check out our latest product features and capabilities here: t:slim X2™ Insulin Pump with Control-IQ™ Technology
In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. We treat our fellow employees like friends and family, and the company like our own home. This universal respect allows us the freedom to be ourselves and to be effective at our jobs, knowing at the end of the day that we can trust everyone to do the right thing, for each other and for the company. You can learn more about our culture and life at tandem here: https://www.tandemdiabetes.com/careers/life-at-tandem and See what our customers are saying here: #tsliminthewild
BE YOU, WITH US!
We’re always looking for awesome, forward-thinking achievers to join our workforce. We are committed to making sure our company fully reflects the diverse consumers who use our product. We are making strides towards this goal and are firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment.
We love a good referral! If you know someone that would be a great fit for this position, please share!
APPLY HERE: https://recruiting2.ultipro.com/TAN1005TDCI/JobBoard/7c56fc7c-1edd-48ec-939c-10225b1f3df1/OpportunityDetail?opportunityId=b916e08d-3f3b-4ac3-92f0-cf5c13009665