Regulatory Affairs Director

3 days ago

San Diego, California, United States CorDx Full time
Job Title: Associate Director of Regulatory Affairs

CorDx is a leading biotech organization dedicated to delivering innovative medical device solutions. We are seeking an experienced Associate Director of Regulatory Affairs to lead our regulatory submissions and ensure compliance with applicable regulations.

Key Responsibilities:
  • Prepare and submit regulatory documents to FDA, including 510(k) and De Novo submissions.
  • Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals.
  • Ensure all products comply with applicable regulatory requirements, including FDA regulations and ISO standards.
  • Provide regulatory guidance to R&D teams during product development life cycle.
  • Stay updated on changes in regulatory requirements and communicate potential impacts to the organization.
Requirements:
  • Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
  • Minimum of 7-10 years of experience in regulatory affairs within the medical device industry.
  • Proven track record of leading and successfully obtaining 510(k) and De Novo clearances/approvals.
  • Experience in interacting with FDA and other regulatory agencies.
Skills & Competencies:
  • In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations.
  • Strong leadership and project management skills, with the ability to manage multiple projects and priorities.
  • Excellent communication, negotiation, and problem-solving skills.
  • Ability to work collaboratively in a cross-functional team environment.
Benefits:
  • Medical Insurance Plan
  • Retirement Plan
  • Paid Time Off
  • Training & Development

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