What are the responsibilities and job description for the Regulatory Compliance Specialist position at Suru?
About the Job
Suru is seeking a highly skilled Regulatory Compliance Specialist to join our team. The ideal candidate will have a deep understanding of regulatory frameworks, extensive experience with technical documentation, and a proactive approach to quality management in a manufacturing environment.
Key Responsibilities:
- Ensure adherence to global regulatory requirements, including ISO standards and FDA regulations, to maintain product quality and compliance.
- Develop, review, and manage complex technical documentation related to quality processes and regulatory compliance.
- Oversee and contribute to critical quality system functions such as process improvements, non-conformance investigations, regulatory audits, and validation efforts.
- Apply statistical process control (SPC) techniques and industry best practices to analyze and optimize manufacturing and quality control processes.
- Leverage extensive industry experience and critical thinking to guide decision-making and strategic planning for quality initiatives.
- Demonstrate strong organizational and planning abilities to manage multiple projects and priorities effectively.
- Communicate clearly and professionally across departments, as well as with external partners, to ensure alignment on quality objectives and compliance requirements.
- Collaborate within cross-functional teams to drive continuous improvement and maintain a high standard of quality.
- Utilize expertise in quality management systems, including deviation handling, document control, product release, and change management, to support business objectives and mitigate risks.
