May 19, 2021

Global Vice President, Regulatory & Quality Affairs

  • Biofourmis
  • Boston, MA
Full time Quality

Job Description

Biofourmis is a rapidly growing, global digital health company filled with committed, passionate professionals who care about augmenting personalized care and empowering people with complex chronic conditions to live better and healthier lives. We are pioneering an entirely new category of medicine by developing clinically validated, software-based therapeutics to provide improved outcomes for patients, smarter engagement & tracking tools for clinicians, and cost-effective solutions for payers. We are collectively devoted to a single-minded idea powering personally predictive care. Our dynamic growth has been marked by quadrupled headcount in the last 12 months via both expansion & acquisition, yielding a global footprint with offices in Boston, Singapore, Bangalore, and Zurich. We are backed by prominent international venture capital investment & have cultivated relationships with worldwide healthcare stakeholders over the last 5 years. Our talented team features numerous PhD’s in Data Science and Biostatistics, over 80 patents, prolific scientific publications, world-class systems, developers & engineers, and leaders in the clinical operations space. Global Vice President, Regulatory & Quality Affairs To realize our robust pipeline, we are seeking a talented and highly motivated executive to join our organization as Global Vice President, Regulatory & Quality Affairs. The successful candidate will be responsible for strategic and functional leadership of Regulatory and Quality initiatives supporting our core platform & broad integrated solution portfolio. This seasoned professional will play a critical role as a core member of our Executive Management Team building the quality and regulatory foundation for our strategic pursuit of growth opportunities in the field of digital therapeutics. Key Responsibilities Direct all activities relating to U.S. FDA and analogous international regulatory compliance, such as clinical research and pre-clearance testing, post-beta commercialization, required clearances and approvals, compliance with quality systems regulations, and other analogous requirements. Lead Quality throughout the entire global organization by elevating to a performance standard expected from a leading multinational digital health company—including training, strategic & tactical guidance, systems building & management, & regular communication with each vertical. Manage a team of high performing Regulatory and Quality professionals to drive excellence within the organization. Develop and implement effective strategies for obtaining necessary regulatory approvals to bring products to market with optimum cost effectiveness and compliance. Ensure timely preparation and filing of organized and scientifically valid submissions. Design record retention practices and oversees audit preparations. Provide expertise in translating regulatory requirements into practical, workable plans. Represent the Company in interactions with relevant regulatory agencies. Already possess or have the ability to build strong relationships with relevant global regulatory bodies to effectuate timely submission clearances. Develop effective systems and ensures compliance with the Company’s global quality assurance programs, including design, manufacturing and test, product assurance, reliability, training, and documentation. Support new product development efforts, including assigning Quality representatives to Product Development Core teams. Provide critical inputs to and/or approvals of all design control elements including test development, protocols, reports, inspection instructions, Design Reviews, Design History Files, etc. Support certification and ongoing compliance processes to all relevant ISO, FDA and international standards (ex. ISO 13845, QSR etc.) by facilitating the development, implementation, monitoring, and improvement of Biofourmis quality management systems and practices Manage and strengthen the infrastructure required to perform the core activities of the Quality Management System, including Deviations, Out of Specification (OOS), Corrective & Preventative Actions (CAPAs), investigations, change control, validations, material disposition, complaints, internal and external audit/inspections, and customer inquiries/questionnaires Collaborate with other functions to assure compliance in support of biopharma services, clinical validation studies, regulatory interactions, and medical device commercialization. Build functional excellence within the Regulatory and Quality organization through excellence in hiring, ongoing professional development & performance management, and organizational design. Maintain an up-to-date knowledge of regulatory procedures to provide analysis and evaluation at set intervals and as needed to ensure compliance and attainment of strategy. Requirements Demonstrated track record leading a critical corporate function; demonstrated success in leading through influence Comprehensive knowledge of ISO and FDA regulations and experience in obtaining certifications, US and international regulatory agency inspections; ASQ CQE and CQA preferred Excellent understanding of and experience implementing Design Control in the context of new product development Understanding engineering, data science, & product development, requirements to support U.S. and international clinical validation studies, and regulatory pathways to commercialization is highly desired Excellent oral and written communication skills with strong technical writing experience required Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence Demonstrated track record of cross-functional influence and engagement Highly organized and detail oriented, with an analytical approach to problem solving and decision making Strong working knowledge and application of the applicable quality and regulatory standards and track record of successful customer audits and regulatory inspections Working knowledge of GCP, GMP, ICH guidelines, & 21CFR Part 11 requirements High ownership level, team orientation, & execution standard Effective, timely communication across the organization Active cross-vertical engagement, assertiveness, & creativity in support of leadership goals Accomplished leadership & solution-based mindset Experience & Education Minimum B.A/B.S. degree, preferably in an engineering or life sciences discipline 10+ years of experience in the biopharmaceutical, healthcare, or life sciences industry, preferably with a medical device-, digital therapeutics-, or diagnostic manufacturing company; 8+ years of experience working in a regulatory affairs department focusing on FDA regulatory submissions (510(k)s, De Novo, Pre-submission applications, etc.), leading technical professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff Experience engaging in direct negotiations with the FDA in resolving issues with submissions, experience preparing and submitting successful original PMAs and a good understanding of the multiple routes to clearance or approval of a diagnostic product Experience and understanding of ex-U.S. regulatory registrations and approvals as well as understanding of HIPAA and the importance of patient data privacy Experience with Software as a Medical Device (SaMD) and wearable sensor devices strongly preferred Proficiency with standard business tools MS Word, Powerpoint, Excel, ERP, CRM, & QMS; experience with Qualio strongly preferred. Knowledge of EU MDR, SaMD, & CDS strongly preferred. Passion for powering personally predictive care. Travel Requirements Occasional travel to support audits & international Q/R Team on location

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