Lead Regulatory Affairs Consultant

2 weeks ago

Princeton, New Jersey, United States Techlink Systems Full time
Job Overview

Position Title: Lead Regulatory Affairs Consultant
Work Schedule: Standard business hours, Monday to Friday

ROLE SUMMARY:
The Lead Regulatory Affairs Consultant is responsible for integrating knowledge of scientific, regulatory, and commercial factors to ensure that i-STAT branded products developed, manufactured, or distributed by Point of Care comply with relevant legislation in the US and EU.

This role holds significant influence at the site/divisional level and is 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.

KEY RESPONSIBILITIES:

  • Compile and maintain submissions for US 510k and EU IVDR Technical Files.
  • Ensure adherence to Corporate and Divisional Policies and procedures within the quality management system.
  • Prepare and review regulatory submissions for both US and EU markets.
  • Identify potential regulatory challenges and emerging issues during the product submission process, collaborating with team members to develop effective solutions.
  • Provide regulatory insights for product lifecycle planning in designated countries/regions.
  • Track the progress of applications under regulatory review and communicate updates to internal stakeholders.
  • Submit necessary reports and ensure timely responses to regulatory authorities.
  • Utilize advanced regulatory knowledge to devise strategies for complex issues.
  • Identify and assess emerging regulatory concerns for the assigned regions.
  • Evaluate the acceptability of quality, preclinical, and clinical documentation for submission purposes.
  • Assess the impact of design changes on registration in the responsible countries/regions.
  • Offer strategic input and technical guidance on regulatory requirements to development teams.
  • Ensure that external communications related to regulatory matters comply with regulations.

LEADERSHIP RESPONSIBILITIES:

  • Provide leadership in projects without direct authority.
  • Guide exempt and non-exempt personnel who have significant autonomy in their roles.

ACCOUNTABILITY AND SCOPE:

  • Manage technical and scientific regulatory activities independently, ensuring deadlines are met.
  • Effectively communicate and negotiate with various regulatory agencies, interpreting and applying regulatory requirements accurately.
  • Work with minimal oversight, determining technical objectives for assignments.
  • Recognized as an expert in regulatory affairs, with completed work reviewed for long-term outcomes.

EDUCATIONAL REQUIREMENTS:

  • Bachelor's Degree in a relevant scientific field (e.g., Biology, Chemistry, Microbiology, Immunology, Medical Technology, Pharmacy, Pharmacology, Engineering) is preferred.
  • A Master's degree in a technical discipline is advantageous.
  • Professional certification (e.g., RAC from the Regulatory Affairs Professionals Society) is a plus.

EXPERIENCE REQUIREMENTS:

  • A minimum of 5 years of experience in a regulated industry such as medical devices or pharmaceuticals.

PREFERRED QUALIFICATIONS:

  • Experience with authoring US 510k submissions or EU MDR/IVDR technical files.
  • Hands-on experience with in vitro diagnostics medical devices.
  • Experience leading cross-functional teams on regulatory and compliance projects.
Company Overview

TechLink Systems is a national staffing services provider with a presence across the USA and global development and support centers. We are a certified minority business and have received numerous accolades for our excellence in staffing solutions.

Our focus is on building strong relationships with clients, acting as an extension of their in-house capabilities to enhance growth, productivity, and competitiveness. We cater to various staffing needs, including contract staffing, direct hire, and project outsourcing.

Our recruiting centers serve enterprise clients, and we specialize in multiple sectors, including Information Technology, Engineering, Customer Service, Finance, Scientific, and more. Our dedicated team of recruiters and HR specialists brings extensive experience from high-performance industries, making TechLink Systems an ideal partner for recruitment process outsourcing.

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