Regulatory Affairs Specialist

3 weeks ago

San Diego, California, United States CorDx Full time

At CorDx, we are seeking a highly skilled Regulatory Coordinator to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.

Key Responsibilities:

  • Assist in the preparation, compilation, and submission of regulatory filings and registrations, including DeNovo and 510(k) submissions for IVD products.
  • Maintain and organize regulatory documentation, including regulatory submissions, approvals, certificates, and correspondences with health authorities.
  • Work closely with R&D, quality assurance, and manufacturing teams to obtain required documentation in compliance with regulatory guidelines and product development life cycle.
  • Maintain current knowledge of relevant regulations, guidance documents, and standards.
  • Provide administrative and project support to the Regulatory Affairs team, including scheduling meetings, preparing agendas, and drafting regulatory reports.
  • Support internal audits and assist in maintaining compliant regulatory documentation according to Quality Management System and in accordance with ISO 13485 and other relevant standards.

Requirements:

  • Bachelor's degree in biology, chemistry, regulatory affairs, or a related field.
  • 2+ years of experience in regulatory affairs, preferably in IVD or medical device industry.
  • Familiarity with FDA regulations, including 21 CFR, 510(k), and ISO 13485 requirements.
  • Strong organizational and project management skills.
  • Excellent written and verbal communication skills.
  • Ability to work collaboratively with cross-functional teams.
  • Detail-oriented with strong analytical skills.

What We Offer:

  • Medical Insurance Plan
  • Retirement Plan
  • Paid Time Off
  • Training & Development

We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.

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