VP of Quality and Regulatory Affairs
VP of Quality and Regulatory Affairs
What’s the position?
TypeZero is seeking a VP of Quality and Regulatory Affairs. This is a full-time job located in Charlottesville, Virginia, and offers benefits and a salary commensurate with experience.
Who are we?
TypeZero Technologies is a digital health and personalized medicine startup dedicated to revolutionizing the treatment and management of diabetes. At TypeZero, we use advanced data science techniques, statistical analysis, proven metabolic models, and modern engineering practices to develop customized analytics tools and blood glucose control solutions to help persons with diabetes improve their health and lives. TypeZero’s current products include a smartphone-based Artificial Pancreas system, therapy optimization tools for healthcare providers, and advisory applications for smart insulin pens.
What’s the role?
We are seeking a highly skilled individual to provide guidance and leadership to ensure regulatory compliance for all of our diabetes management products. This position will require the development and implementation of a quality system while removing complexity and bottlenecks that come with regulatory applications. The main job of the candidate is to ensures appropriate quality management system requirements have been effectively established and implemented to maintain compliance with US FDA’s Quality System Regulation, the European Medical Device Directive, ISO13485, and other relevant domestic and/or international regulatory requirements. The candidate will be able to communicates the status of the quality management system work at management review through the use of established metrics. You will work on difficult problems related to the regulatory plan requiring an in-depth analysis of various factors. Additionally, the position will require leadership and insight into our FDA strategy and pre-submission processes. We expect this role to play an integral part in the strategy formation and product roadmap as TypeZero weighs the technical possibilities versus the regulatory hurdles associated with Class 2 and 3 devices. The role will also oversee all documentation, SOP’s, protocols and reports that will help a growing med tech startup grow and develop. TypeZero offers full benefits, competitive salaries commensurate with experience, company options, a flexible work environment, and an opportunity to solve one of today’s most challenging medical problems.
We like to have fun while tacking important problems, and being able to collaborate with others and work under tight timelines (all with a sense of humor!) is a must. We’re a growing company that is developing its culture as we go. If you think you’re a fit, we’d love for you to join us.
Who are you?
You are an individual with diverse experience in regulatory requirements for medical devices / medical software. You want to work in a field where you make a difference. You are able to take constructive criticism and make revisions in your work quickly, while also confident in your skills to deliver the same to your colleagues. You enjoy the fast paced startup environment that comes with the ability to pivot quickly while making sure you and your team have a fun and productive work environment. You keep up to date with changes with the quality and regulatory landscape in both the US and EU. You ideally will have some knowledge of or connection to diabetes / chronic illness and appreciate the impact of the work that TypeZero will have on innovation and quality of life for those afflicted with these diseases.
Qualifications and Background:
Minimum of a Bachelor’s Degree and substantive experience in life sciences, medical technologies, or extensive equivalent experience necessary to fulfill position requirements. Must have at least 5 years in quality and regulatory roles attached to a software or medical device company. Experience in software processes and the pace of startup is important. At least 3 years of project management experience preferred.
Required Skills and Experience:
- Significant experience with US and European regulatory authorities (e.g. FDA, Notified Bodies) in the product submission, documentation, pre-submission meetings, etc
- Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
- Proven analytical skills and deep understanding of software, data systems, cloud services and mobile applications
- Sense of urgency and perseverance to achieve results
- Professional certification (e.g., CMQ/OE, RAC)
- Thorough knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements, ISO 14971(Risk Management) requirements, Medical Device Directives (MDD) requirements, ISO 62304, Medical Device Software – Software Life Cycle processes
- QMS expertise: Quality planning, policy & regulations, Audit, Validation, process improvement, documentation, training
- Detailed understanding and roles in implementing CAPA systems
- Comfortable performing vendor audits and supplier audits
- Strong familiarity with implementing HIPAA standards in software products.
- Develop and monitor long- and short-term product regulatory plans and oversee implementation of the project plan. Make decisions on issues that could delay project schedules or activities; provide input on budget requirements; monitor project performance against goals.
- Experienced in quality metrics creation, reporting and analysis as well as process improvement techniques.
- Willingness to lead a innovative team through the difficult process of imbedding quality and regulatory thinking into the core DNA of a company.
TypeZero is located in Charlottesville, Virginia, a vibrant and family-friendly town at the foot of the beautiful Blue Ridge Mountains. Charlottesville has been featured as one of the best places to live and visit in the US by companies like Forbes, Travel + Leisure, Kiplinger, and Yahoo. Home to the University of Virginia, Charlottesville is a burgeoning startup environment in the healthcare and biotechnology industries.
How to Apply:
Please send your CV or résumé and a cover letter to email@example.com.