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Regulatory Affairs Specialist

1 month ago

Irvine, California, United States Cynet Systems Full time
Job Title: Regulatory Affairs Specialist

Cynet Systems is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory function, you will provide input on regulatory requirements and ensure compliance with global regulations.

Key Responsibilities:
  • Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements.
  • Presents alternatives for meeting regulatory requirements and resolves moderately complex conflicts between those requirements and development issues.
  • Reviews and approves protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
  • Provides guidance on regulatory requirements necessary for strategic and contingency planning, including developing preliminary regulatory strategic plans.
  • Prepares and oversees documentation packages for submission to global regulatory agencies.
  • Tracks timelines and documents milestone achievements for inclusion in regulatory submissions.
  • Monitors proposed and current global regulations and guidance; assesses the impact of such regulations and guidance on assigned project(s); proposes suggestions on utilizing regulatory updates to expedite the approval process.
  • Reviews labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy.
Requirements:
  • Experience with EU MDR is strongly preferred.
  • Coursework, seminars, and/or other formal government and/or trade association training required.
  • Proven expertise in Microsoft Office, Adobe.
  • Experience in product lifecycle management systems (Agile, Teamcenter, etc.).
  • Excellent written and verbal communication skills and interpersonal relationship skills.
  • Excellent problem-solving, organizational, analytical, and critical thinking skills.
Education and Experience:
  • Bachelor's Degree or equivalent in a scientific discipline (e.g., Biology, Microbiology, Chemistry).
  • 2-4 years of experience required.