VP Regulatory Affairs & Quality Assurance
ALLESET INC
Job Description
Job Description
Global Resources International (GRI) is seeking an experienced and strategic Vice President of Regulatory Affairs & Quality Assurance (RA/QA) to lead global regulatory strategy, quality systems, and commercialization support across highly regulated markets.
This executive leadership role is ideal for a forward-thinking regulatory professional who thrives at the intersection of compliance, innovation, quality, and business growth.
At GRI, we partner with organizations worldwide to deliver operational excellence, strategic solutions, and regulatory leadership that accelerate success in complex industries.
Responsibilities
- Lead global regulatory strategy across FDA, EU MDR, and international markets
- Drive product approvals, submissions, audits, and agency interactions
- Partner with commercial and product teams to accelerate market access and commercialization
- Serve as a senior advisor to clients, regulators, and executive stakeholders
- Oversee Quality Management Systems (QMS) and continuous improvement initiatives
- Build and mentor a high-performing RA/QA organization
- Support strategic growth initiatives, including partnerships and M&A due diligence
Qualifications
- 15+ years of progressive Regulatory Affairs and/or Quality experience
- Deep expertise in FDA, EU MDR, ISO 13485, and global regulatory frameworks
- Strong executive presence with the ability to influence C-suite stakeholders and clients
- Proven success leading regulatory strategy in medical device, pharmaceutical, or life sciences industries
- Experience supporting commercialization and market expansion initiatives
- Passion for leadership, quality excellence, and strategic problem solving
Why Join GRI?
At Global Resources International , we believe regulatory excellence is a competitive advantage. This role offers the opportunity to shape global strategy, strengthen client partnerships, and directly influence organizational growth and innovation.
If you are ready to make a significant impact in a dynamic and growth-focused environment, we would love to connect with you.
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