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Director of Regulatory Affairs- Medical Diagnostic IVD and 510K experience

The world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. Sepsis mortality rate increases >6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic.

Specific Diagnostics has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Used for bloodstream infection Specific’s solution provides results 2 days sooner than existing methods, saving patients suffering from drug-resistant infection.

We have been funded by nearly $30 M in non-dilutive government sponsored research support and recently $17.5 M in venture capital. This is an opportunity to join us at an inflection point in our commercial growth as we bring our first key product to market and with recognition from major customers fueling an expansion of our staff.

The Job

This is a critical role for our growing company and one that works in close partnership with our clinical partners, scientific staff and C-level leadership. As the company’s Regulatory Affairs leader, you will have overall responsibility for the company’s regulatory success. The role spans product and regulatory strategy, ownership of the relationship and engagements with FDA, CE/IVDR notified bodies and other regulatory bodies, and mission critical guidance and collaboration with our scientific, study management to build, submit and see through approval 510(k), CE/IVDR and other submissions. The role also includes building strong relationships with our clinical partners and partnering with the company’s quality system team to assure continued compliance with FDA, ISO and other quality standards.

In depth knowledge of infectious disease diagnostics, preferably in microbiology is needed, our product is an antibiotic susceptibility test system, the FDA team you will interact with and our clinical partners are PhD microbiologists and MDs; only someone with infectious disease expertise can be successful in this role. The job requires in-depth knowledge in all aspects of FDA and CE/IVD regulations as they pertain to in-vitro diagnostics for microbiology. Key responsibilities include:

  • Collaboration with Product Development, Clinical Operations, Manufacturing and Quality to develop, coordinate and execute the regulatory strategies for new product development registrations.

  • Working with development teams to execute strategies for regulatory submissions. Generating regulatory submission plans, and direct document development, review, and finalization.

  • Leading global regulatory submission preparations per plan with minimal to no supervision. Responsibility for obtaining approval including negotiation with the regulators in US and ROW.

  • Interfacing with notified bodies and providing timely responses to notified body questions in order to obtain approval of technical files.

  • Responsibility for writing and updating standard operating procedures (SOP) and work instructions (WI) to support the implementation of IVDR.

  • Contributing to analytical and clinical performance protocols and reports to assure collection of appropriate data for regulatory submissions.

  • Review labels, labeling, and promotional materials for compliance.

  • Preparing “Memo to File” documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvals.

You

  • You have a successful track record of well executed FDA pre-submissions, successful 510(k) approvals for infectious disease diagnostics in microbiology. You are self-driven, capable of figuring out what needs to be done and making it so. You should be excited by the prospect of working in a dynamic, entrepreneurial environment. You should have a track record of success in your education and projects, along with the following characteristics and skills:

  • Experience in development and track record of successful 510(k) clearance of clinical diagnostic/susceptibility assays for infectious disease.

  • Demonstrated experience in authoring Tech files and interfacing with Notified Bodies to obtain CE/IVD.

  • 10+ years infectious disease, medical diagnostic industry experience

  • M.S. in biology, biomedical or other applicable majors

  • Excellent scientific written and oral communication skills as well as interpersonal, organizational, and project management skills. Your submissions must be beautifully, clearly, accurately written.

  • Demonstrated ability to project manage regulatory submissions

  • Demonstrated ability to interpret and implement new regulations

  • Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.

 

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