Regulatory Affairs Consultant Job at ALKU, Irvine, CA

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  • ALKU
  • Irvine, CA

Job Description

Regulatory Affairs Specialist

Overview:

Our client is seeking a skilled Regulatory Affairs Specialist to support the planning, coordination, and execution of regulatory strategies for medical products requiring government approval. This role is ideal for a detail-oriented individual with in-depth regulatory knowledge and proven experience preparing submissions of basic to medium complexity.

Key Responsibilities:

  • Develop and implement regulatory strategies to support product submissions and approvals
  • Prepare, review, and submit regulatory documentation in accordance with applicable regulations and guidelines
  • Interpret and apply relevant healthcare regulations and statutes to ensure compliance
  • Translate complex technical data into clear, concise, reviewer-friendly content
  • Collaborate with cross-functional teams to refine and validate submission data
  • Serve as a liaison with regulatory authorities to support product clearance or approval processes
  • Ensure submissions meet all applicable regulatory requirements and internal quality standards
  • Contribute to the strategic direction of regulatory pathway development for assigned products
  • Act as a resource and mentor for junior regulatory colleagues

Qualifications:

  • Bachelor’s degree in life sciences, engineering, or a related field (advanced degree preferred)
  • 5+ years of experience in Regulatory Affairs within the medical device, diagnostics, or healthcare industry
  • Strong working knowledge of FDA, EU MDR/IVDR, and other international regulatory requirements
  • Demonstrated success in preparing and managing regulatory submissions
  • Experience interacting with regulatory bodies (e.g., FDA, Notified Bodies)
  • Familiarity with submission types such as 510(k), PMA, CE Mark, Technical Documentation
  • Understanding of competitive products and evolving regulatory landscapes

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