Vice President, Regulatory & Quality

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Vice President, Regulatory & Quality in India.

This role offers a strategic leadership opportunity to shape global regulatory strategy and oversee quality assurance across diagnostic and life sciences products. The VP, Regulatory & Quality will lead cross-functional teams to ensure compliance with international regulations, guide product development, and drive continuous improvement in quality management systems. You will collaborate closely with executive leadership, operational teams, and external partners, influencing regulatory pathways and risk management strategies. This position requires a seasoned leader with deep expertise in regulatory affairs, quality systems, and medical device or diagnostic product commercialization. The role is high-impact, combining technical depth, strategic planning, and team development in a fast-paced, innovation-driven environment.

• Lead, mentor, and manage the Regulatory Affairs and Quality Assurance teams, delegating responsibilities and ensuring alignment with corporate objectives.
• Develop, implement, and oversee global regulatory strategies to support commercialization, product approvals, and compliance with FDA, CE, ISO, CLIA, CAP, GxP, and other regulations.
• Provide regulatory counsel, guidance, and training across all company functions, including product development, Medical Affairs, Legal, and Manufacturing.
• Manage preparation, submission, and approval of regulatory filings for US and international markets.
• Oversee Quality Management System (QMS) strategy, processes, and continuous improvement initiatives across the organization.
• Collaborate with internal teams and external partners to ensure product design, operational changes, and clinical programs meet regulatory and quality standards.
• Drive compliance, inspection readiness, risk mitigation, and implementation of quality principles throughout the product lifecycle.

Requirements:

• BA/BS in Life Sciences required; MS, PhD, or advanced degree strongly preferred.
• 20+ years of progressive experience in global regulatory affairs and quality assurance within diagnostics, medical devices, or life sciences technology companies.
• Proven experience leading RA and QA teams, with demonstrated ability to develop and implement strategic plans.
• Expertise in global regulatory submissions, product commercialization, and lifecycle management, including FDA (510k), CE mark, and other international filings.
• Hands-on experience with ISO, CLIA, CAP, CLEP, GxP, and related compliance frameworks.
• Strong leadership, coaching, and mentoring skills, with experience guiding teams in cross-functional and high-growth environments.
• Excellent communication, negotiation, and strategic planning skills to interact with executive leadership, regulatory bodies, and external partners.
• Familiarity with NGS technology, immunology, oncology, or hematology product development preferred.

Benefits:

• Competitive base salary range ($261,000 - $391,600) with bonus and equity eligibility.
• Remote work flexibility with occasional in-person collaboration as needed.
• Opportunity to lead global regulatory and quality strategy for cutting-edge diagnostic products.
• Professional growth through leadership of cross-functional teams and global initiatives.
• Comprehensive benefits, including health coverage, professional development support, and equity incentives.
• Collaborative, innovation-driven, and inclusive work environment.