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Lead Regulatory Affairs Consultant

2 months ago

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

Position: Senior Regulatory Affairs Specialist

Company: Select Source International (SSI)

Job Type: Contractual Engagement

Key Responsibilities:

  • Oversee the preparation and management of regulatory submissions for both US and EU markets.
  • Ensure adherence to relevant Corporate and Divisional Policies within the quality management framework.
  • Proactively identify potential regulatory challenges and collaborate with cross-functional teams to devise effective solutions.
  • Provide regulatory insights to support product lifecycle strategies in designated regions.
  • Track the status of regulatory applications and relay updates to internal stakeholders.
  • Prepare and submit necessary reports while ensuring timely responses to regulatory bodies.
  • Leverage technical expertise to navigate complex regulatory scenarios.
  • Recognize and assess emerging regulatory issues pertinent to assigned regions.
  • Evaluate the suitability of quality, preclinical, and clinical documentation for submission purposes.
  • Conduct impact assessments regarding registration for design modifications.
  • Offer strategic regulatory guidance to development teams regarding compliance requirements.
  • Ensure that all external communications related to regulatory matters are compliant with regulations.
About the Company

Select Source International (SSI) is a consulting firm specializing in IT, Health Care, and Engineering Services, established in 1998. Our team of consultants has consistently delivered outstanding services that have garnered appreciation from clients across various sectors, including Fortune 500 companies and mid-sized enterprises.