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IVD Regulatory Affairs Manager

2 months ago

San Diego, California, United States CorDx Full time
Regulatory Affairs Specialist Opportunity at CorDx

CorDx, a prominent biotechnology firm committed to advancing global health, is seeking a Regulatory Affairs Specialist to enhance our proactive Regulatory Affairs division. In this pivotal role, you will be instrumental in ensuring adherence to FDA standards for our In Vitro Diagnostics (IVD) offerings.

Key Responsibilities:

  • Prepare and submit 510(k) documentation for IVD products.
  • Oversee regulatory submission workflows and liaise with regulatory authorities.
  • Perform regulatory risk evaluations and formulate risk mitigation plans.
  • Keep abreast of regulatory updates and guarantee product compliance.
  • Collaborate with internal teams and offer regulatory insights on various projects.
  • Examine product labeling, marketing materials, and change controls for regulatory compliance.
  • Support the development of regulatory strategies and inform stakeholders accordingly.

Qualifications:

  • Bachelor's degree in Life Sciences, Biotechnology, or Regulatory Affairs.
  • A minimum of 5 years of relevant industry experience, including at least 3 years focused on 510(k) submissions.
  • In-depth knowledge of FDA regulations and procedures related to IVD products.
  • Experience engaging with regulatory agencies, particularly the FDA.
  • Exceptional analytical, organizational, and communication abilities.

Preferred Qualifications:

  • RAC certification or equivalent credentials.

Benefits:

  • Comprehensive Health Care Plan
  • 401K Retirement Plan
  • Generous Paid Time Off
  • Opportunities for Training & Development

CorDx is dedicated to fostering a diverse and inclusive workplace. We value the contributions of all individuals in our mission to enhance global healthcare.