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Director - Regulatory Affairs

Employer
Sherlock BioSciences
Location
United States
Start date
Jul 31, 2022

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Masters Degree/MBA
Position Type
Full time
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Job Details

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 successful candidate will play a critical role in defining, developing and managing Sherlock Biosciences’ regulatory strategy in support of successful submissions across a portfolio of indications for both domestic and international markets. They will be responsible for timely and high quality material submissions assuring the company’s compliance with USFDA and OUS regulations. They will play a critical role throughout product life cycle and will be a key advisor and enabler of successful collaboration both internal and external to Sherlock.

 

Essential Functions

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

  • Develop regulatory strategies including, for example, presubmission, US and OUS, platform (and possibly device family) and assay, and approach to MDSAP and IVDD/IVDR
  • Prepare FDA submissions which may include: facility registration, device listings, 510(k)s, IDEs, FDA meeting requests and associate documentation, de novo submissions, PMAs, CLIA Waiver, etc.
  • Prepare regulatory submissions including the identification, compilation, and submission of information necessary to obtain international regulatory approvals, including export certificates from FDA, and dossiers required by foreign regulatory bodies. Assist foreign licensees with registration of the company’s products in OUS territories
  • Maintain compliance of all approved materials and work cross-functionally on any requested updates or additional studies
  • Communicate with regulatory agencies regarding the status of regulatory information requests and regulatory submissions
  • Communicate with company management regarding regulatory strategy for potential products, new regulatory requirements, trends or risks and the status of regulatory submissions and standings
  • Collaborate cross-functionally to provide guidance to development teams as well as sub-teams to coordinate regulatory strategies and tactics for product development and support
  • Maintain all regulatory files and documentation
  • Develop company/departmental procedures, policies and trainings which assure consistent, accurate, and efficient processing of required submissions
  • Contribute to company QMS procedures to ensure tailorable conformity to regulatory standards
  • Act as lead regulatory reviewer in due diligence for licensing opportunities
  • Supervisory duties and responsibilities may include internal direct reports and external vendor management
  • Review product complaints for completeness of investigation information and assess complaints for MDR or vigilance reporting requirements; submit MDR or vigilance reports as required; maintain MDR/vigilance report files

 Competencies

  • Communicate 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 & Development
  • Change Leadership
  • Technical Skills/Professional Knowledge

 Supervisory Responsibilities

  • May have direct reports

 Work Environment

  • The work environment is a standard office environment or remote setup

 Physical Demands

  • May require extended hours sitting

 Travel Required

  • At least 20% travel may be required (to company, conferences, suppliers, trade shows, regulatory bodies,etc)

 Required Education and Experience

  • Advanced degree in scientific or related field preferred
  • 8-10 years of experience in regulatory affairs including minimum 5 years in a team leadership role for IVD companies
  • Demonstrated success creating pre-market and 510K submissions (preference given for previous PMA submissions)
  • Hands-on capability in all areas of regulatory submission and regulatory compliance execution
  • Experience writing and processing FDA and international submissions
  • Experience processing MDR & Vigilance reports
  • Experience communicating directly with FDA, Notified Bodies, and OUS Competent Authorities/Ministries of Health
  • In-depth knowledge of FDA regulations, EU regulations and applicable FDA Guidance and international standards
  • Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders
  • Demonstrated leadership and self-motivation. Possesses the ability to motivate and guide subordinates to meet objectives
  • Excellent communications skills (oral and written); effective communications to regulatory authorities as well as to superior, peer and subordinate levels
  • Strong organizational and interpersonal skills

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).

#LI-Remote'

Company

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.

Find Us
Website
Phone
617.612.8209
Location
40 Guest Street
Boston
MA
United States
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