Lead Regulatory Affairs Consultant

2 weeks ago

Princeton, New Jersey, United States Select Source International Full time
Job Overview

Position Title: Lead Regulatory Affairs Consultant

Location: Remote

Contract Duration: 12 Month contract with potential for extension based on performance

The role of a Lead Regulatory Affairs Consultant involves leveraging expertise in scientific, regulatory, and commercial matters to ensure that i-STAT branded products developed, manufactured, or distributed by Select Source International comply with the necessary regulations in the US and EU.

This position requires the individual to have significant influence at the site/divisional level and to be recognized as a subject matter expert in international regulations pertinent to the assigned countries/regions. The consultant may represent the department in cross-functional projects that support product launches, market expansions, or compliance initiatives. Responsibilities include analyzing regulatory requirements, identifying necessary data, sourcing this data using available resources, and ensuring that it is well-organized and presented for product registration in the US/EU.

Key Responsibilities:

  • Compile and maintain submissions for US 510k and EU IVDR Technical Files.
  • Ensure compliance with relevant Corporate and Divisional Policies and procedures under the quality management system.
  • Prepare and review regulatory submissions for both US and EU markets.
  • Proactively identify regulatory challenges and emerging issues throughout the product submission process, collaborating with regulatory and related teams to develop solutions.
  • Provide regulatory insights for product lifecycle planning in the assigned countries/regions.
  • Monitor applications under regulatory review and communicate progress to internal stakeholders.
  • Submit necessary reports and ensure timely responses to regulatory authorities.
  • Utilize technical regulatory expertise to propose strategies for complex issues.
  • Identify and assess emerging regulatory issues for the assigned countries/regions.
  • Evaluate the acceptability of quality, preclinical, and clinical documentation for submission.
  • Conduct registration impact assessments for design changes in the assigned countries/regions.
  • Offer strategic input and technical guidance on regulatory requirements to development teams.
  • Ensure that external communications for regulatory purposes adhere to regulations.

Leadership Responsibilities:

  • Provide leadership without direct authority, acting as a project leader.
  • Guide and direct exempt and non-exempt personnel who operate with significant independence in their tasks.

Accountability and Scope:

  • Manage and execute technical and scientific regulatory activities for the assigned countries/regions, functioning independently on regulatory submissions with minimal oversight.
  • Effectively communicate and negotiate with various regulatory agencies, interpreting and applying regulatory requirements accurately.
  • Work is conducted with a degree of autonomy, allowing for flexibility in determining technical objectives.
  • Completed work is evaluated from a long-term perspective to ensure desired outcomes.
  • Recognized as a discipline expert and resource in regulatory affairs.

Minimum Qualifications:

  • Bachelor's Degree in a relevant scientific field (Biology, Chemistry, Microbiology, Immunology, Medical Technology, Pharmacy, Pharmacology, Math, Engineering, or Medical fields) is preferred.
  • A Master's degree in a technical area is advantageous.

Certification such as RAC from the Regulatory Affairs Professionals Society is a plus.

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