Senior Regulatory Analyst

Company: Oncocyte

Position: Senior Regulatory Analyst

Location: Irvine, CA

Posted: January 10, 2022

Who we are:

Oncocyte is a precision diagnostics company with a mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey.

Mission of the role:

We are seeking an experienced Senior Regulatory Analyst. The successful candidate will be responsible for providing Regulatory Affairs support to the product development and pharma services. This position will provide strategic and tactical support to the Product Development team in Irvine, CA, and the Pharma Services team located in Nashville, TN, and will report to the Director of Quality and Regulatory Affairs. This position is responsible for defining and executing the regulatory strategies and subsequent submissions to support key product development programs and pharma services. In addition, they will ensure adherence to established processes, policies, and procedures of the company and external regulatory agencies.

Focus Areas / Projects:

  • Regulatory Submission Authorship and Review
  • IVD / LDT Product Development and Commercialization (EU / US)
  • Design Controls and Design Change Management
  • Quality Risk Management
  • Technical Report Authorship and Review
  • Quality Management Systems (QMS) Support
  • Auditing and gap assessments of QMS/DHF/RMF/technical documentation

Your day-to-day:

  • Responsible for executing regulatory strategy, providing regulatory guidance and support to product development teams for strategic planning, design, and development, and post-market surveillance and compliance activities.
  • Writes, coordinates compiles, and submits Regulatory documents to FDA and other Regulatory Agencies, including International Authorities, including Pre-submission documents, PMA and /or 510k submissions, CE/IVD Technical Files.
  • Engages regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, address questions, etc.
  • Services as RA subject matter expert and keeps current in regard to US and International regulations, guidance documents, Federal Register notices, and competitor news
  • Coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.;
  • Conducts training and/or communicates appropriate materials, as needed, in order to enhance the team’s knowledge of working in a regulated environment.
  • Reviews and approves proposed labeling, packaging, advertising, and promotional materials after evaluating conformance to regulations
  • Participates in business meetings with existing and prospective external partners
  • Conducts audits/gap assessments of quality system documentation, regulatory submissions, design history files, risk management files, and technical documentation against industry regulations and standards (US/EU/ROW)
  • Directly support and provide subject matter expertise related to all disciplines of Regulatory but not limited to complaints handling and adverse event reporting, design controls, risk management, and quality management systems
  • Identifies and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
  • Compile and review information relating to regulatory submissions, inspections, or response letters to regulatory bodies

What it takes to do this job:

  • Bachelor’s or Master’s degree in regulatory affairs or science-related discipline or engineering from an accredited institution
  • Industry certifications (e.g., RAC, ASQ) are preferred.
  • 3+ years of IVD Regulatory Affairs experience. This experience must include either 510(k) and/or PMA Submissions. CE-IVD experience is desirable.
  • Demonstrated experience in multiple aspects of regulatory affairs, including; strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
  • Experience representing RA on project core teams providing active and successful regulatory guidance and RA strategy.
  • Successful experience in communicating with Regulatory Agencies

Who you are:

  • Demonstrated experience in preparing FDA submissions (IND/NDA/IDE/510(k)/PMA)
  • Working knowledge of Quality System requirements (FDA Part 820, Parts 210/211, Part 4, and ISO 13485)
  • Working knowledge of design controls (FDA 21 CFR 820.30 / ISO 13485)
  • Working knowledge of device risk management (ISO 14971)
  • Working knowledge of EU in vitro diagnostic requirements (IVDD and IVDR) preferred
  • Ability to work on several projects, retaining quality and timelines, and can prioritize workload with minimal supervision
  • Highly organized
  • Resourceful, Self-directing, self-pacing, fast learner
  • Excellent analytical and communication skills, particularly writing skills, are essential
  • Pleasant and positive communication style

You will have the opportunity to:

  • Improve patient outcomes.
  • Meaningfully impact the company’s short-term and long-term success.
  • Work collaboratively across all levels within the organization.
  • Grow your role as you see fit.
  • Learn everything there is to know about cancer diagnostic laboratories.
  • Create an inspiring workplace.