The Quality and Regulatory Leader will oversee all aspects of quality management and regulatory compliance related to our SaMD products. This role is critical to ensuring that the software solutions meet international standards and regulatory requirements while maintaining the highest levels of data security and patient safety. The ideal candidate will have a solid background in the quality and regulatory landscape for SaMD and experience in start-up environments, where flexibility and innovation are key.
Key Responsibilities:
- Develop, implement, and maintain quality management systems (QMS) compliant with IEC 62304 for the development and maintenance of SaMD.
- Ensure adherence to ISO 27001 for information security management, aligning our processes with the highest standards for data protection and cybersecurity.
- Oversee compliance with IEC 81001, ensuring the safety and effectiveness of health software systems.
- Lead regulatory submissions, including preparing technical files for CE marking, FDA submissions, and other global regulatory pathways for SaMD products.
- Drive continuous improvement in product quality, patient safety, and risk management processes.
- Collaborate closely with product development, engineering, and cybersecurity teams to ensure that regulatory and quality requirements are integrated into product design and development processes.
- Act as the primary point of contact with regulatory bodies and notified bodies, managing audits, reviews, and inspections.
- Support the development and execution of regulatory strategies to accelerate time to market while ensuring full compliance.
- Provide training and guidance on regulatory and quality management best practices to cross-functional teams.
Qualifications:
- Bachelor's or Master’s degree in a relevant field (e.g., Biomedical Engineering, Computer Science, Regulatory Affairs, or similar).
- Extensive experience with IEC 62304 for medical device software development lifecycle processes.
- Proven expertise in ISO 27001 (information security) and IEC 81001 (health software safety) standards.
- Strong knowledge of global regulatory environments for SaMD (e.g., FDA, EMA, MDR, etc.).
- Demonstrated experience leading quality and regulatory initiatives in a start-up or high-growth company, with the ability to adapt to dynamic, fast-paced environments.
- Excellent understanding of risk management principles and methodologies as per ISO 14971.
- Strong leadership, communication, and collaboration skills, with the ability to influence and drive cross-functional teams.
- Experience managing audits and regulatory inspections.
- Problem-solving mindset with a proactive approach to identifying regulatory solutions and quality improvements.
What Is On Offer:
- Competitive salary and benefits package.
- Opportunity to work in a dynamic, fast-paced start-up environment with a talented, mission-driven team.
- Flexible working arrangements (remote/hybrid options).
- Professional growth opportunities, including leadership development and exposure to global regulatory markets.
- Be part of a company that is making a real impact on healthcare and patient outcomes.
Please send your updated resume to emily.james@skillsalliance.com or call +1 646 889 8093 for further details.
