Key Responsibilities:
Research and Development (R&D):
Lead and oversee the company's R&D initiatives to develop innovative products and solutions.
Collaborate with cross-functional teams to ensure alignment of R&D goals with business objectives.
Monitor industry trends and technological advancements to maintain the company's competitive edge.
Prepare and manage budgets for R&D projects, ensuring optimal resource allocation.
Quality Management:
Develop, implement, and maintain the company’s quality management system (QMS) in compliance with international standards such as ISO 9001 or ISO 13485.
Conduct regular quality audits and inspections to ensure adherence to established procedures and standards.
Manage and resolve product quality issues, ensuring prompt corrective and preventive actions (CAPA).
Train employees on quality protocols and best practices to foster a culture of continuous improvement.
Regulatory Affairs:
Ensure the company’s products comply with all relevant local, regional, and international regulatory requirements.
Prepare and submit regulatory filings, including product registration, certifications, and renewals.
Act as the primary liaison with regulatory agencies and authorities, addressing inquiries and ensuring timely approvals.
Keep the organization updated on changes in regulatory policies and standards, adapting company processes as needed.
Documentation and Reporting:
Maintain comprehensive records of quality and regulatory processes, audits, and certifications.
Generate detailed reports and presentations for internal and external stakeholders on quality and regulatory performance.
Develop and update standard operating procedures (SOPs) to reflect regulatory requirements and quality standards.
Team Collaboration:
Work closely with the operations, manufacturing, and sales teams to ensure product quality and compliance throughout the lifecycle.
Support cross-departmental training on regulatory and quality matters.
Qualifications:
- Bachelor’s degree in Chemistry, Life Sciences, Engineering, or a related field (Master’s preferred).
- Strong knowledge of regulatory frameworks such as FDA, CE, or CFDA, and quality standards like ISO 9001 or ISO 13485.
- Excellent organizational and communication skills, with the ability to manage multiple tasks and meet deadlines.
- Proficiency in regulatory documentation and quality management software is a plus.
- This expanded job description ensures clarity in the role’s expectations and responsibilities while providing a comprehensive overview for potential candidates.
