The Vice President, Regulatory Affairs & Quality Management is in charge of providing subject matter expertise on all matters related to FDA and medical device regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department. The Vice President will represent Click Therapeutics in key stakeholder and strategy meetings on all regulatory matters related to Software as a Medical Device (SaMD), including meetings with executive leadership, meetings with FDA and other regulators, and working with our development partners. This role will lead the strategy, preparation, review and submission of documents to the FDA and other global regulatory authorities to support product marketing authorization and lifecycle management. This role must be able to combine scientific, regulatory and business knowledge to assure that our products are developed and distributed according to all applicable regulations for SaMD in alignment with the company’s strategic goals. We are looking for a leader who has a mastery of medical device regulations and has demonstrated capacity to develop efficient solutions to the evolving regulatory needs of this industry, including a record of successful FDA submissions and meetings, and experience aligning study designs with regulatory evidence requirements. The VP will be expected to build out a global regulatory affairs capacity at Click, including recruiting, mentoring and leading a team of regulatory professionals, and to guide and support our existing Quality Management team in implementing a robust quality management system aligned with best practices in agile software development. This role will have high exposure across all functional areas within Click and externally with multiple key audiences, such as scientific and clinical advisors, regulators, and investors, and will advocate for the continuous advancement of the science and regulation of digital therapeutics.
This is a highly visible, creative, and agile role within a rapidly growing pre-IPO company in a nascent and fast-growing space. The role will be located in our trendy TriBeCa HQ, includes great benefits, and is an excellent wealth-building/equity opportunity for the right individual.
Secure US and global regulatory marketing authorization for new products, product updates and product expansions. This includes preparation and filing of submissions, responding to regulatory authorities and auditors, and leading meetings with regulatory authorities.
Grow, develop and lead the regulatory affairs team to scale with the expanding needs of the organization, both in the US and globally.
Develop and implement a comprehensive set of policies, processes and SOPs in support of the regulatory affairs function.
Formulate regulatory strategies for pipeline products and the Click platform. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop strategies for resolution.
Perform global regulatory intelligence including monitoring regulatory updates, workshops, discussions, and other news sources. Advance internal awareness of current and upcoming regulations, requirements and expectations, and identify training and educational needs for the organization.
Manage processes involved with maintaining annual licenses, registrations and listings.
Oversee advertising and promotional review to ensure regulatory compliance.
Serve as the internal go-to subject matter expert on regulatory matters concerning software as a medical device. This includes providing regulatory advice and oversight to other functional areas.
Represent the company in external meetings on regulatory matters, including with regulators and auditors, development partners, scientific and clinical advisors, and the investment community.
Oversee and support the Quality Management team, including in quality management systems implementation, regulatory authority inspections, post-market surveillance, complaint handling, CAPAs and product recalls, and all other relevant compliance obligations.
Bachelor's Degree required, preferred in life sciences, health care, or related discipline.
10+ years of experience in medical device regulatory affairs.
A comprehensive understanding and experience with implementation of medical device regulations, including all relevant sections of Title 21 of the US Code of Federal Regulations and the European Union Medical Device Directive (MDD) and/or Regulation (MDR).
Familiarity with the legal basis of FDA’s regulatory authority, including the US Food, Drug & Cosmetic Act and all related amendments.
Experience with regulatory matters concerning Software as a Medical Device (SaMD) and/or Software in a Medical Device (SiMD).
Record of successful medical device filings, including 510(k), De Novo, PMA and/or CE Mark.
Familiarity with drug regulations and regulatory pathways, including drug-device combination products.
Experience with Quality Management Systems and applicable regulatory compliance requirements.
Expertise in GxP requirements for clinical, manufacturing and other relevant practices.
Understanding of the principles and requirements of promotion, advertising and labeling.
Prior experience with international medical device regulatory requirements and marketing authorization.
Excellent writing and oral communication skills.
Ability to form and maintain working professional relationships with external stakeholders, regulatory authorities and scientific and clinical advisors.
Prior experience and demonstrated ability to work in diverse therapeutic areas.
Strong leadership skills with ability to set a vision, lead change, grow a team and mentor others.
Certification in regulatory affairs (such as RAC from the Regulatory Affairs Professionals Society)
Prior leadership or management experience in the regulatory affairs department of a medical device company that develops class II products
Experience with digital therapeutics
Experience with artificial intelligence and machine learning
Experience with combination drug-device products,
MS or PhD in a technical area
JD or other legal training
Internal Number: 1789
About Click Therapeutics
Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for people with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Following a groundbreaking clinical trial, Click’s industry-leading smoking cessation program is available nationwide through a wide variety of payers, providers, and employers. Click’s lead prescription program is entering into a multi-center, randomized, controlled, parallel-group, phase III FDA registration trial for the treatment of Major Depressive Disorder in adults. Major pipeline expansion and progression is in process.