Associate Director Regulatory Affairs

4 weeks ago

Watertown, United States Sherlock Biosciences Full time
Job DescriptionJob DescriptionSalary:

Overview

Sherlock Biosciences is dedicated to providing global access to the simplest and most accurate diagnostic tests that empower individuals to control their own healthcare. We are creating a new generation of CRISPR and Synthetic Biology-based molecular diagnostic technology platforms that can rapidly deliver accurate and inexpensive results in any setting. We envision a world where Sherlock’s products will enable users to make more effective decisions in any environment, including hospitals, industrial settings, low-resource settings, and at home. Successful candidates will join an exciting, collaborative, and fast-paced company that seeks to disrupt diagnostics and change the trajectory of human health.


 

Job Description

 

Summary/Objective

The Associate Director of Regulatory Affairs is responsible for establishing and executing a bold regulatory strategy enabling FDA approval or clearance for home and professional use of molecular diagnostic assays based on Sherlock’s isothermal amplification, CRISPR, and Synthetic Biology technologies.  Scope includes providing regulatory guidance to cross-functional development teams; establishing relationships with FDA; developing a bold regulatory strategy in support of our commercial strategy; with cross-functional support, writing and managing regulatory pre-subs and submissions; regular interactions with FDA and global regulatory personnel to keep submissions moving toward approval or clearance.  Success in this role is dependent on a strong background in global regulatory clearances/approvals and CLIA waiver for IVD products, preferably for point-of-care or point-of-need uses.  Also critical is the ability to work with a cross-functional development team and to manage multiple parallel submissions in a startup environment.

 

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

  • Establish regulatory strategy that supports sale of OTC IVD products in the shortest reasonable timeframe, and provides for their reimbursement when used in professional settings
  • Navigate regulatory gray areas effectively by interpreting and applying FDA guidelines to support the over-the-counter marketing of our innovative STI diagnostics product, taking into account the absence of established OTC STI precedents.
  • Preparation, submission and follow-up on FDA pre-subs. Develop and implement strategies for timely submission, FDA follow-up, and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc.
  • Identify, assess and manage third-party organizations as necessary to support regulatory compliance and submissions.
  • Provide input and guidance to cross-functional development teams on analytical studies and endpoints necessary as input to regulatory submissions; ensure development Records are suitable for regulatory scrutiny.
  • Provides expertise in translating regulatory requirements into practical, workable plans.
  • Provide input to development teams on translation of clinical sensitivity and specificity to analytical performance requirements.
  • Collaborate with Sherlock leadership to identify opportunities and risks and navigate technical obstacles.
  • Prepare, submit and manage De Novo, 510(k), CLIA waiver and IVDR submissions leading to approval to sell OTC
  • Proactively identify areas where seeking Agency feedback would enhance regulatory clarity and compliance, and initiate meetings with the FDA to address potential challenges before they escalate, ensuring proactive and strategic regulatory management.

 

 

Competencies

  • Communicating with Impact
  • Decision Making & Problem Solving
  • Taking Initiative and Follow-up
  • Planning and Organizing
  • Project Management
  • Building Effective Partnerships
  • Team Building
  • Business Acumen
  • Adaptability
  • Coaching and Development
  • Possess Organizational Savvy
  • Drive Positive Disruption
  • Enable & Activate Equity
  • Visionary
  • Change Leadership
  • Technical Skills/Professional Knowledge

 

Supervisory Responsibilities

  • This position may have supervisory responsibility

 

Work Environment

  • When on site, standard office and laboratory environment, including BSL 2

 

Physical Demands

  • The physical demands require the ability to lift up to 20 lbs
  • The physical demands may require standing on your feet for multiple hours in a laboratory

 

Travel Required

  • Travel may be required for this position

 

Required Education and Experience

  • 12+ years of experience in regulatory affairs for IVD assays with a demonstrated track record of bringing new, clinically actionable products to market
  • BS in chemical or biological science, MS preferred
  • Experience working within IVD regulatory requirements including CLIA waiver
  • Proven track record of successful 510(k) and CLIA waiver submissions, and preferably De Novo submissions, as well
  • Strong technical understanding of user workflow for molecular diagnostics, including associated safety risks
  • Proven ability to communicate and collaborate cross-functionally – from technical to commercial and across technical disciplines
  • Excellent organizational skills and ability to creatively solve ambiguous challenges
  • Familiarity with isothermal amplification and CRISPR and the data necessary to demonstrate their performance to global regulatory bodies is preferred
  • Familiarity with challenges associated with clearance and commercialization of consumer healthcare products is preferred

 

Work Authorization/Security-Clearance Requirements

Must be eligible to work in the United States.

 

Affirmative Action/EEO Statement

Diversity, Equity, and Inclusion are not merely trendy buzz words to us; they are part of our core values.  We are committed to creating a community of well-rounded professionals from all ethnicities, nationalities, educational backgrounds, and genders.  This “melting pot” of differences is what fosters ideas and innovations. Our beliefs span beyond our walls and into the world, as reflected in outreach to various underserved domestic and global communities.


Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job.  Duties, responsibilities, and activities may change at any time with or without notice.


Other

Sherlock requires employees to be fully vaccinated pursuant to Company policy (policy allows for potential exemptions for medical or religious reasons, consult with Human Resources for more information)

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