Lead Quality and Regulatory Affairs Specialist

2 weeks ago


Santa Clara, California, United States Intellectt Inc Full time

Position: Senior Quality/Regulatory Affairs Specialist

Company: Intellectt Inc

Role Overview:

As a Senior Quality/Regulatory Affairs Specialist, you will play a pivotal role in ensuring compliance and quality within the regulatory affairs sector. Your expertise will be essential in supporting the regulatory affairs team from a quality assurance and compliance standpoint.

Key Responsibilities:

  • Provide comprehensive support to the regulatory affairs organization focusing on quality and compliance.
  • Conduct audits related to regulatory affairs to ensure adherence to standards.
  • Oversee Corrective and Preventive Actions (CAPAs) for the regulatory affairs team.
  • Utilize your experience in medical devices to enhance compliance processes.
  • Develop and maintain a Key Performance Indicator (KPI) dashboard, ensuring compliance metrics are met. Proficiency in Excel and PowerPoint is essential; experience with Power BI is a plus.
  • Collaborate with the regulatory affairs team to streamline processes that facilitate the execution of submissions across various regions.
  • Manage the processes that ensure submission requirements are met effectively.

Qualifications:

  • A minimum of 7 years of experience in the quality sector of the medical device industry is required.
  • Strong project management skills with the ability to prioritize and manage multiple tasks efficiently.
  • Excellent communication skills and a keen attention to detail are essential.
  • A background in Quality Assurance may be beneficial for this role.

Education:

A Bachelor’s degree in a relevant field (Science or Engineering) is required.

Additional Information:

Candidates should be prepared to provide detailed examples of their experience during the interview process, as clarity and depth of knowledge are crucial.

Interview Process:

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



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