Who we are
binx health has the world’s fastest FDA-cleared molecular platform for CT/NG testing. We also have the broadest suite of offerings in at-home testing for large corporate partners for broadened access to STI and COVID-19 care. Our molecular point of care platform brings rapid, accurate, and convenient infectious disease testing to people where they live, work, and shop. Our at-home solutions offer front-end engagement, and end-to-end logistics in concert with our reference lab partners to offer partners “turn-key” answers for their infectious disease testing needs. Our solutions broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere, including in the ever-expanding footprint of retail health. Our suite of medical guideline-driven, at-home testing solutions for STIs and COVID-19 are designed to reach the many who are unwilling or unable to visit a physical location.
The Director, Regulatory Affairs will develop and implement effective regulatory and related strategies for the development and commercialization of binx products. Working closely with binx leadership, this position is responsible for developing and executing global regulatory affairs strategies, plans, and programs for binx product development programs and products as well as supporting compliance by interpreting relevant regulations. The individual will develop, lead and drive approvals of products, taking into account U.S. and OUS regulatory requirements, and provide regulatory expertise and guidance to binx team of internal stakeholders. Additionally, the Director, Regulatory Affairs also ensures that there are regulatory strategies in place to address US and OUS labeling requirements.
- Provide regulatory expertise and guidance within binx collaborative cross-functional teams
- Establish and implement, in collaboration with leadership, global strategic regulatory goals for binx’s development programs and approved products
- Develop content, format, prepare and file regulatory amendments, marketing applications, and other regulatory submissions, and work closely with functional leaders of the company to produce high-quality submissions
- Provide strategic input on all key development documents
- Serve as primary contact for Regulatory Agency interactions for binx products and establish excellent relationships with regulatory agency personnel. Responds to requests for additional data organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding the company’s filings.
- Guide binx’s transition to IVDR and UKCA compliance.
- Together with the Sr. Director, Quality Assurance, prepares, coordinates, and directs all efforts with FDA interactions, including site visits and audits
- Collaborate with binx colleagues to support regulatory milestones and goals for product development, as well support regulatory goals for trial design
- Contribute to clinical study design strategy and execution, working in concert and collaboration with research, development, and clinical teams
- Interpret scientific and clinical data and lead the development of labeling to optimize product potential benefit-risk ratio.
- Anticipate and identify regulatory risks and make recommendations to senior management regarding risk mitigation
- Lead and manage the authoring and coordination of periodic regulatory and/or safety reports for investigational and approved binx products
- Lead and manage the authoring and coordination of approved product reports to regulatory agencies
- Establish and manage an electronic archive and catalog all submissions to and communications with regulatory agencies
- Liaise with external vendors and binx support teams to maintain productive relationships, supporting efficient regulatory document preparation and submission activities
- Lead the post-marketing regulatory activities for binx, such as planning and managing post-approval regulatory submissions, advising marketing and sales management regarding regulatory aspects of product education and promotion activities
- Other duties as assigned
Education, Experience, and Demonstrated Skills
- Requires a BA/BS degree, Master’s degree, or Ph.D. preferred.
- Required 8 – 10 years related experience within the digital health/medical device industry along with successful experience in the development and completion of regulatory submissions such as 510(k), PMAs, IDEs
- A high level of familiarity and understanding of US and OUS regulations and guidelines, broadly across digital health and diagnostics
- Proven record of leadership and managing regulatory/quality organizations with global responsibility and establishing long-term strategic growth initiatives.
- Experience with all phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization.
- Experienced in regulatory filings for US (510(k), IDE, and PMA) and other key countries/regions.
- Current knowledge of US and international in vitro diagnostic regulations and guidelines.
- Demonstrated success in the development and implementation of facility quality management systems and assuring compliance to all applicable regulations.
- Good working knowledge of applicable regulations and harmonized standards (21CFR820, ISO13485:2016)
- High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
- Excellent interpersonal and strong leadership skills; self-motivated and flexible to changing schedules.
- Willingness to regularly travel to our UK offices
binx health, Inc. is an Equal Opportunity Employer
For interested applicants, please submit resumes to: firstname.lastname@example.org