Job Description

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

• Lead the development and evolution of a harmonized, enterprise-wide Quality Management System (QMS), aligned with global regulatory requirements.
• Ensure that quality systems support the full product lifecycle—from R&D and design to manufacturing, distribution, and post-market surveillance.
• Oversee QA/QC functions globally to ensure the consistent production of high-quality, safe, and compliant products that meet or exceed customer expectations and regulatory standards.

Compliance, Risk Mitigation & Audit Readiness

• Establish and manage systems for monitoring compliance across the organization, identifying emerging risks and implementing mitigation strategies.
• Ensure the company maintains readiness for regulatory inspections, third-party audits, and internal quality assessments; personally lead resolution efforts in response to audit findings or compliance issues.
• Partner with Legal and Supply Chain to assess and manage quality and regulatory risks related to suppliers, partners, and contract manufacturers.

Cross Functional Collaboration:

• Act as a trusted partner to cross-functional teams, embedding quality and regulatory compliance into business decisions and innovation processes.
• Collaborate with R&D to ensure new products are designed and developed in accordance with regulatory requirements and patient safety standards.
• Support Sales and Marketing teams with regulatory intelligence and strategic insights that inform go-to-market planning, labeling, and global market entry.

Organizational Leadership and team development:

• Lead, mentor, and develop a high-performing global RA/QA team, cultivating a culture of transparency, accountability, and continuous improvement.
• Define roles, responsibilities, and career development plans to build team capabilities and ensure succession readiness.
• Promote knowledge sharing and best practices across regions to ensure consistency, agility, and operational discipline across the global organization.

Operational Excellence and Continuous Improvement:

• Drive the adoption of best practices in quality systems, compliance processes, and documentation control.
• Champion Lean, Six Sigma, and other process improvement methodologies to enhance regulatory and quality performance across the business.
• Establish and track global performance metrics and KPIs for RA/QA functions, using data to identify trends, drive improvements, and report to executive leadership.

The Candidate

Experience and Professional Qualifications

Education:

• Bachelor's degree in a relevant field (e.g., Biomedical Engineering, Regulatory Affairs, Quality
• Assurance, Business, Life Sciences). Advanced degree preferred.

Experience :

• Minimum of 15 years of progressive leadership experience in Regulatory Affairs and Quality Assurance within the medical device, life sciences, or health tech industries.
• At least 10 years in a senior leadership or executive role with global scope and cross-functional influence.
• Proven success leading U.S. and international regulatory submissions, including 510(k), PMA, De Novo, and IVDR, and navigating regulatory approvals in major global markets.
• Deep experience in building, managing, and optimizing ISO 13485-certified QMS systems and leading organizations through regulatory inspections and third-party audits.
• Track record of driving regulatory strategy in support of innovation, market expansion, and product lifecycle management.

Technical & Leadership Competencies

• Expertise in global regulatory frameworks and ability to interpret and apply complex regulatory requirements across multiple jurisdictions.
• Strong operational mindset, with experience aligning regulatory and quality goals with broader commercial strategy.
• Demonstrated ability to influence at all levels of an organization and across external agencies, even without direct authority.
• Outstanding communication, interpersonal, and negotiation skills with a collaborative and adaptable leadership style.
• Financial and business acumen to assess regulatory risks and opportunities in the context of overall company performance and strategy.
• Committed to fostering an inclusive, diverse, and high-performance team culture.

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.

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