Quality Assurance and Regulatory Compliance Expert
2 weeks ago
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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