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Apply now for the position of Head of Quality Management and Regulatory Affairs, LAM
Location: Brazil, Chile, Colombia, México
Mission and Position headline:
Lead the Quality management & Regulatory Affairs function across the LAM region, ensuring compliance, product safety, and operational excellence across commercial operations and customer services.
Drive and execute regional quality and regulatory strategies, translating requirements into practical business actions that enable market access, customer satisfaction, and sustainable growth.
Serve as the Quality Representative for assigned legal entities and champion a pragmatic, risk-based approach that balances regulatory compliance with business objectives.
Your tasks and responsibilities:
- Quality Management & Continuous Improvement
- Maintain and continuously improve the Quality Management System (QMS) to meet regulatory and business requirements.
- Ensure effective execution of Quality Assurance and Quality Engineering processes (e.g., audits, training, documentation, CAPA, nonconformance management).
- Identify and mitigate quality risks in commercial operations through structured risk management.
- Drive process improvements that increase efficiency, product quality, and customer satisfaction.
- Leverage digital tools and data insights to enhance quality performance, transparency, and decision-making.
- Ensure inspection readiness across all markets in the region, manage external inspections and internal audits.
- Regulatory Strategy & Compliance
- Define and execute the regional regulatory strategy that supports business growth objectives, ensuring timely submissions, approvals, and adherence to country-specific requirements.
- Ensure full compliance with internal policies and external regulations, with a strong focus on product safety and market access. Translate regulatory requirements into clear business implications and actionable guidance for leadership teams.
- Act as key interface to health authorities and external stakeholders, representing the organization with credibility and impact.
- Commercial & Customer Quality
- Establish governance framework, ensuring Commercial teams, Customer Services teams and Business Partners operate in accordance with local requirements and corporate quality standards.
- Ensure product integrity and compliance across commercial operations and customer services.
- Ensure on time and accurate Post Market Surveillance & Reporting
- Partner with customer-facing teams to resolve quality issues and improve the end-to-end customer experience.
- Leadership & Stakeholder Management
- Embed a strong quality culture focused on continuous improvement and customer-centricity.
- Build and lead a high-performing and engaged regional Quality & Regulatory team, driving accountability, capability, and ownership.
- Collaborate closely with global Quality and cross-functional teams to align standards, share best practices, and ensure consistent execution.
- Lead interactions with local authorities to support regulatory compliance, product lifecycle activities and business continuity across the region.
Your qualifications and experience:
- 10–15+ years in Quality and/or Regulatory Affairs within medical device / pharma, including leadership responsibility.
- Strong experience with QMS, regulatory submissions/approvals, inspections (e.g., FDA/NMPA), and product safety/compliance frameworks.
- Proven track record in international, matrix organizations and multi-market environments.
- Degree in life sciences, engineering, or related field.
Competency Requirements:
- Demonstrated leadership across multiple markets in the region.
- Deep expertise in Quality & Regulatory frameworks, including QMS, audits, and authority interactions.
- Ability to translate quality and regulatory requirements into clear business actions and decisions, including effectively managing quality and compliance risks across direct and indirect markets within the region.
- Strong analytical, data-driven, and problem-solving mindset.
- Effective stakeholder management and communication in global, cross-functional settings.
- Proven ability to lead, develop, and drive performance of high-performing teams.
- High ownership, execution focus, and change agility.
Desired Outcomes:
- Balanced quality and regulatory compliance with business growth
- Strengthened commercial and customer services quality excellence
- Proactively managed quality and regulatory risks
- Established high-performing and engaged organization
Who we are:
We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work:
When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
As an equal opportunity employer, we welcome applications from individuals with disabilities.
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