Position Overview:
We are seeking an experienced and results-driven Head of Quality Assurance & Regulatory Affairs to lead our quality and regulatory functions. This senior-level role is pivotal in ensuring compliance with global medical device regulations and maintaining the highest standards of quality throughout the product lifecycle. The ideal candidate will have deep expertise in quality assurance, regulatory strategies, and experience working within the medical device industry.

Key Responsibilities:

1. Quality Assurance Leadership:

• Develop and implement a comprehensive Quality Management System (QMS) aligned with ISO 13485, FDA 21 CFR Part 820, MDR, and other applicable regulations.

• Oversee quality control processes to ensure product integrity and compliance with regulatory standards.

• Lead internal and external audits, ensuring readiness and compliance for regulatory inspections.

• Promote a culture of quality excellence throughout the organization.

2. Regulatory Affairs Strategy:

• Develop and execute regulatory strategies to support product approvals and compliance in global markets.

• Manage the preparation, submission, and maintenance of regulatory filings, including 510(k)s, PMAs, CE marking, and other market-specific requirements.

• Monitor changes in regulations and standards, providing proactive guidance to internal teams to ensure continued compliance.

3. Cross-Functional Collaboration:

• Partner with R&D, manufacturing, and clinical teams to ensure design controls, risk management, and regulatory requirements are met during product development.

• Act as the primary regulatory and quality liaison with external stakeholders, including regulatory authorities and notified bodies.

4. Risk Management and Compliance:

• Oversee the development and execution of risk management plans in line with ISO 14971.

• Investigate and address non-conformities, CAPAs, and customer complaints, ensuring robust corrective actions are implemented.

• Maintain compliance with post-market surveillance, adverse event reporting, and product recall requirements.

5. Leadership and Team Development:

• Build, mentor, and lead a high-performing quality and regulatory team.

• Foster a collaborative and innovative approach to solving complex regulatory and quality challenges.

Qualifications and Experience:

• Bachelor’s degree in engineering, life sciences, or a related field; advanced degree preferred.

• 10+ years of progressive experience in quality assurance and regulatory affairs within the medical device industry.

• Deep knowledge of global medical device regulations (FDA, ISO 13485, MDR, IVDR, etc.).

• Proven track record of successful regulatory submissions and product approvals in major markets.

• Demonstrated expertise in quality systems, audits, and risk management.

• Strong leadership, organizational, and problem-solving skills.

• Excellent communication and interpersonal skills, with the ability to interact effectively with regulatory bodies and internal teams.

Preferred Skills:

• Experience with digital health or software as a medical device (SaMD).

• Proficiency in regulatory tools and electronic quality management systems (eQMS).

• Certification in regulatory affairs (RAC) or quality management (e.g., ASQ CQE/CQA) is a plus.