Regulatory Affairs Specialist

We are looking for a Quality & Regulatory Lead to head the quality and regulatory domain at our company, taking ownership of regulatory and quality strategy across our client portfolio.

The role involves hands-on involvement in projects spanning medical devices, medical software, SaMD, and AI platforms — including the preparation and maintenance of regulatory documentation required for product approvals.

You will work directly with diverse clients while staying current with international regulatory standards including ISO, FDA, and MDR.

Key responsibilities:

• Lead the quality and regulatory domain across the company.
• Define and drive regulatory strategy for clients in the medical device space.
• Prepare and review regulatory documentation including quality procedures, risk management files, software documents, and submission packages.
• Collaborate with client-side teams — including R&D, quality, and operations — to ensure regulatory compliance.
• Manage medical device approval processes with relevant regulatory authorities.
• Conduct internal audits and lead preparations for external audits.
• Respond to regulatory authorities and represent the company with clients, industry bodies, and stakeholders.

Requirements:

• 7+ years of experience in regulatory affairs for medical devices, SaMD, or a related field.
• Proven experience working with regulatory authorities and managing regulatory documentation.
• Strong knowledge of software and risk management standards: ISO 14971, IEC 62304, ISO 13485.
• Solid understanding of privacy and data security requirements: HIPAA, GDPR, ISO/IEC 27001.
• Bachelor's or Master's degree in Life Sciences, Engineering, or a related field.
• Familiarity with medical cybersecurity standards: FDA Cybersecurity Guidelines, IEC 81001-5-1.

Nice to have

• Experience preparing STRIDE threat models, software risk analyses, and security architecture design.
• Experience working with AI platforms in the healthcare industry.
• Background in software development.