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Medical Device, Quality/Risk Management, Regulatory Compliance, Worldwide Regulatory Affairs
4 Year Degree
The Vice President, Clinical & Regulatory is responsible for overseeing the development and execution of the Company’s worldwide Clinical and Regulatory strategies for Tandem’s innovative hardware and software products and related services across domestic and international markets. Provides expertise and guidance in interpreting government regulations, agency guidelines, and internal policies to assure compliance with global standards. Serves as the top representative in the Clinical and Regulatory departments for both internal and external functions. Directs the 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.
PRIMARY DUTIES & RESPONSIBILITIES:
Oversees the Clinical 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 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.
Oversees the design, implementation and conduct of innovative clinical trials.
Identifies and develops strong collaborative relationships with study investigators, clinical sites and external service providers.
Maintains accountability for all relevant timelines and deliverables. Leads clinical team to secure global regulatory approvals for pipeline products.
Provides strategic consultation and guidance to external and internal subject matter experts with regard to go/no-go development decision criteria on significant clinical components and implications.
Oversees implementation of safety strategy across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues. Manages timely reporting of clinical trial issues to regulatory authorities and the generation of clinical study reports.
Participates in defining and developing broad strategies consistent with business objectives and clinical and regulatory requirements.
Ensures that New Product Development teams have appropriate clinical and regulatory representation for all key development programs.
Supports the development of strategic and tactical plans for all regulatory and clinical submissions including all US and OUS filings, ensures completeness, administrative and scientific accuracy; facilitates timely government approvals for marketing new and modified products.
Provides leadership to a team of Clinical Training Coordinators (CTCs), participating in development, performance appraisal, merit recommendation, and promotion of staff.
Represents Tandem by acting as a liaison between external collaborators and internal stakeholders.
Partners with Quality, 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 regulatory risks and benefits of business plans, including directing alternative action plans based on risk/benefit analyses.
Participates as a member of the executive team in defining the strategy, direction and vision of the organization.
Confers with other executive leaders to coordinate and prioritize planning.
Interfaces directly with Board of Directors and regulatory agencies regarding clinical and 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.
Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
Other responsibilities as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
Strong knowledge and understanding of the job to oversee the clinical and regulatory functions of a medical device company operating globally.
Experience with clinical and 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.
15 plus years related experience or equivalent in medical device industry.
5 plus years’ experience in a senior management role in a commercial stage company with global operations.
Proven success overseeing multi-site clinical trials and complex regulatory submissions for global enterprise.
Sets strategy for the functional area(s) and, as a member of the Executive Team, for the corporation.
Directs and controls the activities of functional area(s) through directors and/or managers, ensuring product requirement and customer support needs are met.
Erroneous decisions will have a long-term effect on the company’s success.
Internal Number: 12657U2020
About Tandem Diabetes Care
Tandem Diabetes is a medical device company that has revolutionized the diabetes community by inventing the first color touch screen insulin pump. We have become the fastest growing insulin pump company in the world and we are the first to automate the insulin delivery process. Our whole reason for being is to make the lives of people with diabetes better and better, through relentless innovation and revolutionary customer experience.
“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. In the development of our first product, the t:slim® Insulin Pump, we conducted thousands of interviews with people living with diabetes and their healthcare providers, and have continued using this design approach in the development of all of our products. We believe that by listening to the needs of both patients and providers, we have a better chance of delivering products that will help improve their lives.
Our strategy is to excel in our areas of expertise and to partner with other technology leaders to create products that combine the best option...s available. We believe that true progress is made through collaboration. Our commitment to innovation through partnerships also extends to leading researchers in the artificial pancreas space, and Tandem technology has been used in artificial pancreas research around the world.