Regulatory Affairs Director

6 days ago

Oxford, Oxfordshire, United Kingdom SciPro Full time

**About SciPro**

We are a leading provider of innovative medical solutions, specializing in AI-powered imaging biomarkers. As an exclusive partner of Brainomix, we are committed to delivering high-quality products that meet the highest regulatory standards.

**Job Summary**

We are seeking a highly experienced Senior Quality Assurance Manager to join our team. As a key member of our leadership team, you will be responsible for overseeing the quality management system, ensuring compliance with regulatory requirements, and driving continuous improvement.

**Key Responsibilities**

  • **Lead the Quality Function**: Oversee the quality management system, ensuring it is aligned with regulatory requirements and industry best practices.
  • **Regulatory Compliance**: Maintain current FDA, CE, and other regulatory clearances, and lead regulatory submission efforts for new products.
  • **Quality Management System**: Oversee the implementation and maintenance of the company's Quality Management System (QMS).
  • **Internal and External Audits**: Ensure compliance through internal and external audits, and implement corrective actions as necessary.
  • **Collaboration**: Collaborate with Clinical, R&D, Development, Marketing, and Technical Support teams to ensure regulatory compliance throughout the product lifecycle.
  • **Leadership**: Serve as the most senior Regulatory/QA leader within the business, providing guidance and support to team members.

**Requirements**

  • **Education**: Degree in a scientific field.
  • **Experience**: Minimum 4 years' experience in regulatory affairs within the medical device industry.
  • **Regulatory Affairs**: Experience in SaMD regulatory affairs or software integrated into active medical devices.
  • **Technical Documentation**: Proven track record in drafting, compiling, and submitting technical documentation for CE certification.
  • **Regulatory Authorities**: Experience in liaising with regulatory authorities and Notified Bodies, including negotiation.
  • **Regulatory Processes**: Hands-on experience with regulatory processes and submissions under MDR.
  • **Clinical Evidence**: Involvement in development and clinical evidence activities to ensure regulatory compliance.
  • **Communication**: Ability to translate, summarize, and clarify technical and scientific information for both internal and external communication.

**Nice to Have**

  • **Clinical Evidence**: Knowledge of Clinical Evidence and Clinical Evaluation Report (CER) requirements.
  • **PMS**: Understanding of PMS requirements.
  • **Medical Device Regulatory**: Knowledge of medical device regulatory requirements.

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