Quality Assurance & Regulatory Affairs Specialist

As the Quality Assurance & Regulatory Affairs Specialist you will be responsible for building and leading the company’s regulatory and quality foundation from the ground up. In this role, you will be expected to develop and implement a scalable QMS, prepare relevant projects for global regulatory submissions, and drive a culture of quality across the organization.

Key Responsibilities

Develop and Implement Regulatory & Quality Strategy

• Define, develop, and execute regulatory strategy for SaMD approval in key global regions.
• Establish a fit-for-purpose Quality Management System (QMS) aligned with ISO 13485, 21 CFR Part 820, and other relevant standards.
• Prepare, lead, and manage regulatory submissions and communications with authorities.
• Ensure readiness for audits and facilitate inspections from regulatory authorities and certification bodies.

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

• 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.

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