Head of Quality and Regulatory Affairs
2 months ago
Overview
We are seeking a dedicated and experienced Head of Quality and Regulatory Affairs to join the team of an exciting start-up based in Cambridge. As the Head of Quality and Regulatory Affairs, you will be responsible for ensuring that the company complies with all industry regulations and standards while maintaining the highest level of quality in their products. You will play a critical role in developing and implementing quality control systems and regulatory strategies to support the company's objectives.
Responsibilities
Develop and implement quality management systems to ensure compliance with industry standards and regulations
Oversee regulatory affairs activities to ensure timely submissions and approvals for new products and variations
Collaborate with cross-functional teams to establish and maintain quality assurance processes and procedures
Provide guidance and leadership in quality and regulatory matters, including training and mentoring staff
Conduct internal and external audits to identify areas for improvement and ensure adherence to regulations
Keep abreast of changes in quality standards and regulatory requirements and implement necessary modifications
Represent the company in interactions with regulatory agencies and other external stakeholders
Qualifications
Bachelor's degree in a related field, such as Life Sciences or Engineering
Proven experience in a quality or regulatory role within the Life Sciences industry
Strong understanding of quality management systems and regulatory requirements
Excellent communication and leadership skills
Ability to interpret complex regulatory requirements and apply them to business practices
Regulatory Affairs certification or relevant professional accreditation is preferred
Day-to-day
Review and approve quality documentation and regulatory submissions
Lead meetings with cross-functional teams to discuss quality and regulatory strategies
Provide guidance and support to staff on quality and regulatory compliance issues
Stay updated on industry regulations and standards to ensure ongoing compliance
Collaborate with external partners and regulatory agencies to gather information and address any concerns
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