Regulatory Director


Job ID 18-00197

Industry Pharma

Job Type Permanent

Location Bridgewater, NJ

Description

This central NJ biotech company is dedicated to improving patient outcomes through early detection of colorectal cancer. The company's products span the full spectrum of colorectal cancer testing, including InSure® FITTM, a fecal immunochemical test for screening in healthy adults, to COLVERATM, a proprietary blood test identifying circulating tumor DNA in patients post-treatment for early detection of recurrence and residual disease. Company is committed to developing and delivering solutions that provide physicians and their patients with information to help guide earlier and better treatment decisions in cancer care management. Company continues to apply its proprietary innovation in molecular pathology to commercialize other diagnostic tools in other cancer types. Company has offices and CLIA-certified laboratories in Bridgewater as well as FDA- registered and TGA-certified IVD manufacturing in Edison, New Jersey and Sydney, Australia and a NATA-accredited laboratory in North Ryde, NSW Australia.

This role will function under the corporate business group as a consultative Regulatory resource across subsidiaries to support global initiatives and market introductions. Reporting to the VP Regulatory Affairs.
Core responsibilities:

  • Plan, coordinate and execute regulatory strategy including writing and reviewing submissions for In Vitro Diagnostics (IVDs) to FDA and other agencies internationally, and clinical laboratory regulators, both domestic and international. Maintain licenses, registrations and technical files.
  • Establish and foster relationships with regulators and monitor the regulatory landscape for changes and assessing the corresponding impact for the business.
  • Develop, implement and maintain relevant regulatory procedures for compliance with applicable regulations and associated training including but not limited to regulatory submissions, notices and agency interactions, associated record keeping requirements, registration and licensing practises.
  • Identify departmental concerns and business risks, escalating as appropriate to relevant stakeholders. Liaise across departments to forecast commercial consequences of regulatory activities.
  • Support global Quality Management System development, implementation and oversight of regulatory files and processes
  • Participate in product development – assisting in preparing regulatory strategy, reviewing Design History File deliverables for substantiation of regulatory submissions and compliance, participation in risk analysis and design reviews, review of clinical trial master files and other associated trial deliverables
  • Serve as subject matter expert for the Regulatory department as needed with responsibility across the product lifecycle, both pre-market and post-market. Including support required for manufacturing and marketing processes.
  • Maintain current professional and best practice knowledge. Completes required continuous training and education, including department specific requirements.
  • Other duties as assigned


Qualifications

Qualifications:

  • Authorization to work in the United States indefinitely without restriction or sponsorship
  • Education: Bachelor's degree in Engineering, Science, Healthcare or similar

Experience:

  • 10y US regulatory submissions and file maintenance experience required for medical devices or IVDs. Including participated and lead 510k, CLIA waiver and PMA, with molecular assays (equivalent experience will be considered).
  • Agency experience highly regarded (FDA or equivalent)
  • Prefer global regulatory experience
  • Prefer additional Quality Systems experience (SOP writing, reviewing and approving), Auditing experience (certification preferred).
  • Working knowledge with 21CFR820, ISO13485, ISO14971 (CLIA and US state DOH regulations for laboratories preferred)
  • Basic lab experience – pipetting, GLP, hazard awareness

 

Attributes

  • Able to organise and track complex information, attention to detail, efficiency focussed
  • Interpret regulatory requirements, communicate context to the team internally and translate to practise
  • Good technical writer – able to write, review and edit technical documentation for clarity, organisation, structure and simplicity
  • Effective communicator, enjoys training, collaboration and team work
  • Independent and autonomous, ability to plan, prioritise, manage projects and tasks to timelines.
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate high quality documentation, follow instructions, and comply with company policies
  • Strong collaboration, problem solving and analytical skills, must be analytical, flexible, innovative, and self-motivated
  • Must have the flexibility to work extra hours to meet departmental goals and availability to shift hours enabling work across time zones when required
  • Passion for contributing to a growing and successful international business
  • Thrive on opportunity to excel and contribute
  • Demonstrates high ethical standards in business practices. Actively supports organizational goals and changes as they occur. Communicates goals in positive, supportive manner.
  • Conduct must reflect the Company's values and a commitment to the Code of Conduct ethics and compliance program.