Senior Vice President of Regulatory and Quality

Purpose of the Position

The Senior Vice President of Regulatory and Quality will play a critical role overseeing all regulatory and quality assurance activities within the company. Reporting to the Chief Executive Officer, you will lead the global regulatory function and influence a culture of quality throughout the organization. In this role, you will ensure the delivery of high-quality products in full compliance with all applicable regulations and standards, including FDA 21 CFR Part 820 (Quality System Regulation), ISO 13485 : 2016, the Australian Therapeutic Goods (Medical Devices) Regulations [TG(MD)R Schedule 3], the Canadian Medical Devices Regulations (SOR / 98-282), and Japan's MHLW Ministerial Ordinance No. 169. You will drive continuous improvement initiatives, support regulatory strategy and submissions, and lead both the regulatory and quality teams to uphold operational excellence and regulatory compliance.

This is a high-impact role for an experienced, collaborative, and forward-thinking regulatory and quality leader who thrives at the intersection of innovation, compliance, and global business growth. The successful candidate will bring a passion for excellence, a deep understanding of international regulatory landscapes, and the ability to foster alignment, trust, and shared accountability across newly integrated teams and systems.

Essential Duties and Responsibilities

Strategic Leadership & Regulatory Oversight

• Develop and implement a comprehensive global regulatory strategy that ensures compliance with U.S. and international regulations, including FDA, ISO 13485, IVDR, USDA, PMDA, and other applicable bodies.
• Oversee and guide the preparation, submission, and successful clearance / approval of regulatory submissions including 510(k), De Novo, PMA, IVDR dossiers, and Q-Submissions.
• Serve as the company's lead representative in interactions with global regulatory authorities and industry partners, building strong relationships and maintaining ongoing engagement to influence regulatory pathways and support business goals.

Quality Management & Compliance

Compliance, Risk Mitigation & Audit Readiness

Cross Functional Collaboration :

Organizational Leadership and team development :

Operational Excellence and Continuous Improvement :

The Candidate

Experience and Professional Qualifications

Education :

Experience

Technical & Leadership Competencies

Note : This job description is intended to convey information essential to understanding the scope of the position and is not an exhaustive list of skills, efforts, duties, responsibilities, or working conditions associated with it. Tasks and responsibilities may be subject to change based on business needs and at the discretion of management.