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