Training & Process Implementation:

• Lead training initiatives to ensure all relevant teams understand and adhere to QMS and regulatory requirements.
• Develop and maintain standard operating procedures, compliance documentation, and internal audit processes.
• Serve as the internal authority on quality and regulatory matters, advising leadership and project teams.
• Monitor relevant regulatory changes and update internal systems and policies accordingly.

Cross-Functional Collaboration:

• Work closely with biomedical, clinical, engineering, and marketing teams to embed quality and regulatory considerations into every phase of development.
• Ensure that project timelines and product goals are aligned with regulatory requirements.
• Communicate regulatory risks and solutions to non-regulatory stakeholders.

Requirements

Personal Traits:

• Empathetic understanding of user and stakeholder needs, especially across varying stages of product maturity and regulatory environments.
• Excellent communication and mediation skills, with the ability to convey complex regulatory and quality concepts to both technical and non-technical stakeholders.
• Collaborative team player who thrives in cross-functional environments involving engineering, clinical, marketing, and executive stakeholders.

Must Haves:

• Demonstrated experience in quality assurance and/or regulatory affairs in the medical device, diagnostics, or digital health industry.
• Track record of hands-on experience with regulatory submissions and interactions with authorities in at least one major jurisdiction.
• Strong working knowledge of ISO 13485, ISO 14971, IEC 62304, and other relevant SaMD standards.
• Experience preparing for and supporting audits and inspections by regulatory bodies or notified bodies.
• Demonstrated success in leading or implementing a QMS.

Nice to Have:

• Direct experience with SaMD regulatory pathways.
• Experience working within a MedTech or health tech company, preferably in a fast-paced or startup environment.
• Experience navigating multi-region regulatory strategies
• Familiarity with cybersecurity, privacy, and clinical evaluation requirements for digital health products
• Experience working in or for a company that achieved first-time regulatory approval