The Associate Director, Regulatory Affairs is a key member of Adaptive responsible for supporting the development and operations teams compliance with U.S. and global regulatory requirements. As a member of the Product Core Teams, the candidate for this position will be responsible for understanding and translating regulatory intelligence, scientific, operational and business knowledge into effective strategy and implementation plans. This role will work cross-functionally to lead key regulatory submissions, including leading the regulatory aspect of communications with regulatory authorities and key business partners.
Key Responsibilities and Essential Functions
Apply knowledge of regulatory frameworks and external environments to devise regulatory solutions for the Adaptive product lifecycle, including with FDA, CLIA, CAP, IVDR, and other regulatory frameworks.
Manage regulatory strategy and implementation for filings of new product introductions and expanded indications, including providing organization guidance for requirements and authorizing/reviewing regulatory filing documentation
Manage submissions in multiple ex-US jurisdictions, including the EU, Canada, Australia, Japan, and ASIAPAC, others, and assume responsibility for regulatory component of IVDR compliance.
Develop strategy and evaluate proposed products for product classification and appropriate regulatory pathway.
Ultimate responsibility for reviewing and approving relevant regulatory filing documentation.
Responsibility for communications with the U.S. and global regulatory agencies as the lead contact person, and will be responsible for organizing meetings, submitting minutes, and responding to agency requests.
Provide timely regulatory assessments to support Adaptive’s change control process, including changes to registered products both in the U.S. and globally.
Contribute to process development of post-market reporting and surveillance, and lead agency communications in the event of notifiable non-conformances or adverse events
Own and manage applicable regulatory processes and documents related to R&D and Operations
Work with quality system process owners to identify and interpret applicable regulations and to mitigate any gaps
Work cross-functionally with clinical affairs, project management, product development, marketing, quality, and other teams to provide guidance on applicable regulatory requirements across wide range of activities, including development and commercialization of validated LDT, IVD, and CE Marked products.
Maintain proficiency with evolving science, technical applications, regulatory science and public health policy to determine appropriate application for development, review and oversight of new products.
Advanced degree in relevant science, medical or technical field and 10+ years of overall experience and a breadth of regulatory activities in a medical device and/or diagnostics company involved with development, manufacturing, testing and distributing clinical products.
Demonstrated leadership skills in guiding successful, cross-functional core and/or project teams
Experience with U.S. and international IVD regulations required.
Experience managing regulatory filings with the FDA, EU, and other ex-US regulatory bodies is highly preferred.
Requires 3 years of supervisory experience.
Deep understanding of business needs and strategy. Ability to attain high institutional IQ to create opportunities and solutions.
Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively in cross-functional project teams and with regulators.
Broad knowledge of post market surveillance regulations, practices, and procedures.
Organized and detail-oriented.
High level of accountability, initiative, and integrity. Ability to integrate the Adaptive core values into successful products.