What are the responsibilities and job description for the Regulatory Affairs Expert position at Suru?
At Suru, we value innovation, quality, and regulatory compliance. As a Quality Assurance Manager, you will be responsible for ensuring that our cleanroom facility operates efficiently and effectively while meeting the highest standards of quality and regulatory compliance. The ideal candidate will have a strong background in quality management, cleanroom operations, and regulatory affairs, as well as excellent leadership and communication skills.
The successful Quality Assurance Manager will be responsible for leading quality assurance activities, managing cleanroom operations, and ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 regulations. They will also develop and implement quality policies, procedures, and work instructions to ensure product quality and regulatory compliance.
Key qualifications for this role include:
• Bachelor's degree in Engineering, Quality Management, Life Sciences, or a related field.
• Minimum of 5-7 years of experience in medical device manufacturing, with at least 3 years of experience in a cleanroom environment.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP requirements.
• Experience managing cleanroom operations in a regulated manufacturing environment.
• Demonstrated experience with CAPA, root cause analysis, non-conformance management, and process validation (IQ/OQ/PQ).
The successful Quality Assurance Manager will be responsible for leading quality assurance activities, managing cleanroom operations, and ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 regulations. They will also develop and implement quality policies, procedures, and work instructions to ensure product quality and regulatory compliance.
Key qualifications for this role include:
• Bachelor's degree in Engineering, Quality Management, Life Sciences, or a related field.
• Minimum of 5-7 years of experience in medical device manufacturing, with at least 3 years of experience in a cleanroom environment.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP requirements.
• Experience managing cleanroom operations in a regulated manufacturing environment.
• Demonstrated experience with CAPA, root cause analysis, non-conformance management, and process validation (IQ/OQ/PQ).
