Quality Assurance and Regulatory Compliance Expert

2 weeks ago


Santa Clara, California, United States Intellectt Inc Full time

Position: Senior Quality/Regulatory Affairs Specialist

Company: Intellectt Inc

Role Overview:

We are seeking a highly skilled professional to support our regulatory affairs team with a focus on quality and compliance. This role requires a deep understanding of quality systems and regulatory processes within the medical device sector.

Key Responsibilities:

  • Provide quality assurance support to the regulatory affairs organization.
  • Conduct audits to ensure compliance with regulatory standards.
  • Oversee Corrective and Preventive Actions (CAPAs) related to regulatory affairs.
  • Develop and maintain a Key Performance Indicator (KPI) dashboard, ensuring compliance metrics are tracked effectively.
  • Utilize Excel and PowerPoint proficiently; experience with Power BI is a plus.
  • Collaborate with the regulatory affairs team to enhance operational processes.
  • Ensure that submission processes align with regulatory requirements.

Qualifications:

  • Minimum of 7 years of experience in quality assurance within the medical device industry.
  • Strong project management skills with the ability to prioritize tasks effectively.
  • Excellent communication skills and attention to detail.
  • A background in Quality Assurance is advantageous.
  • Bachelor's degree in a relevant field (Science or Engineering).

Interview Process:

The selection process will consist of two rounds of video interviews.



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