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Compliance Specialist - Exempt

LanceSoft Inc

Join our team as a Compliance Specialist in beautiful Northridge, CA, where you will play a vital role in ensuring the safety and compliance of our medical devices. This position offers a flexible hybrid work schedule, allowing you to enjoy the vibrant local community while contributing to impactful projects.

Key Qualifications

  • Experience with medical device recall/field corrective actions and a strong understanding of FDA/international regulations.
  • Proficiency in data analysis and reporting for recalls.
  • Exceptional critical thinking, attention to detail, and effective communication skills.
Primary Responsibilities
  • Prepare product bounding/scoping, tracking, and execution for medical device recalls.
  • Collaborate with various departments/teams to gather recall-related information, prepare documentation, maintain records, and resolve issues.
  • Document and analyze recall data and prepare reports for internal stakeholders and regulatory agencies, in accordance with regulatory requirements.
Additional Responsibilities

Responsibilities may include the following and other duties may be assigned:
  • Develop, implement, administer, and certify compliance policies, procedures, and practices.
  • Ensure alignment with legal and ethical standards of the organization.
  • Provide compliance advice, investigate complaints, and verify deficiencies are corrected.
  • Develop employee communication and training programs focused on the elements of a companywide compliance program.
  • Enforce antibribery and anticompetition laws.
  • Analyze metrics and audit functional compliance programs.
  • Maintain current knowledge of laws for financial, advertising, and marketing reporting, regulations, and industry guidance that impact the company's compliance program.
Required Education and Experience
  • Bachelor's degree (preferred in Life Sciences/Engineering).
  • 2-5 years of relevant experience.
Work Environment
  • Preferred onsite (hybrid) in Northridge, CA with flexible 3 days onsite, 1st shift.
Vacancy posted 2 days ago
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