Staff Global Regulatory GPO in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Staff Global Regulatory GPO based in the United States.

This role plays a critical part in shaping and maintaining global regulatory compliance across a complex, fast-evolving diagnostics environment. You will define and execute regulatory strategies that ensure products, documentation, and processes meet worldwide requirements across their full lifecycle. Acting as a key global connector, you will help standardize regulatory workflows, strengthen labeling and documentation governance, and ensure alignment across multiple business and commercial functions. The position combines strategic oversight with hands-on regulatory execution, with direct influence on product development, commercialization, and compliance readiness. You will also contribute to improving global systems and tools that support regulatory lifecycle management at scale. Working in a highly collaborative and matrixed environment, you will partner across regions and functions to drive consistency and regulatory excellence. This is a high-impact role with visibility across global operations and regulatory leadership teams.

• Develop, implement, and execute global regulatory strategies ensuring compliance across product registration, lifecycle management, labeling, and promotional material governance.
• Oversee regulatory workflows and tools used to manage global product lifecycle activities, ensuring efficiency, consistency, and compliance.
• Define and maintain global labeling requirements and regulatory procedures, ensuring alignment with international regulations and internal standards.
• Review and govern marketing, advertising, promotional, and training materials (MAPSS) to ensure compliance with applicable regulatory requirements.
• Partner closely with Business Unit and Commercial Regulatory Affairs teams to align global strategies, share best practices, and drive cross-functional initiatives.
• Support regulatory readiness for internal and external audits, inspections, and global compliance assessments.
• Evaluate evolving global regulatory requirements and translate them into actionable guidance for stakeholders across the organization.

• Bachelor’s degree in biological sciences, biomedical engineering, chemistry, or related field with 9+ years of relevant experience; or Master’s degree with 7+ years; or PhD with 4+ years.
• Strong understanding of global regulatory frameworks, with the ability to critically assess applicability and impact on products and processes.
• Experience in regulatory affairs, ideally within in-vitro diagnostics or other highly regulated life sciences industries.
• Ability to develop clear, structured regulatory documentation, assessments, and stakeholder-ready presentations.
• Strong cross-functional collaboration skills, with experience working in matrixed and global environments.
• Excellent written and verbal communication skills, with the ability to translate complex regulatory topics into actionable business guidance.
• Proficiency in Microsoft Office tools and regulatory documentation systems.
• Strong leadership, influence, and decision-making abilities, with the capacity to drive alignment across diverse teams.

• Annual salary range: $140,000 – $170,000, plus bonus and incentive eligibility.
• Comprehensive benefits package including medical, dental, vision, and retirement (401k) plans.
• Paid time off and programs supporting overall well-being and work-life balance.
• Flexible remote work arrangement with the option to work from home.
• Opportunity to shape global regulatory frameworks within a highly innovative diagnostics environment.
• Exposure to international regulatory strategy, product lifecycle governance, and cross-functional leadership.
• Inclusive, collaborative culture focused on continuous improvement and professional development.