Position: DX Head of Regions Quality Management and Regulatory Affairs Head
Location: US East coast
Mission / Position summary:
- Lead the Regional Quality & Regulatory Affairs organization across North America, EMEA, APAC, and Latin America, driving a harmonized, standardized, and high-performing operating model that ensures regulatory compliance, product safety, and operational excellence across Commercial Operations and Customer Services.
- Serve as the Regional Head of Quality & Regulatory Affairs for North America, ensuring compliance, product quality, and business continuity across commercial operations and customer services.
- Develop and execute regional Quality & Regulatory strategies, translating regulatory requirements into pragmatic business actions that enable market access, customer satisfaction, and sustainable growth.
- Act as the Quality Representative for assigned legal entities, fostering a risk-based quality culture that balances regulatory compliance with business objectives.
Key responsibilities:
Global Regions leadership
- Lead and develop the Regional Quality & Regulatory leadership teams across EMEA, APAC, and Latin America, driving capability, accountability, and performance.
- Establish a harmonized global operating model by standardizing Quality & Regulatory processes, governance, tools, and best practices across all regions.
- Drive consistency in Quality Management Systems, regulatory execution, performance metrics, and continuous improvement while enabling appropriate regional flexibility.
- Foster cross-regional collaboration, knowledge sharing, and operational excellence to improve efficiency, compliance, and customer outcomes.
Quality Management & Continuous Improvement NAM
- 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.
Regulatory Strategy & Compliance NAM
- Define and execute the regional regulatory strategy, 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 NAM
- 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 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.
Your qualifications and experience:
- 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 success leading Quality & Regulatory organizations in complex, international matrix environments.
- Experience driving global process harmonization, standardization, and implementation of Quality Management Systems across multiple countries and cultures.
- Degree in Life Sciences, Engineering, or a related discipline.
Competency Requirements:
- Deep expertise in Quality & Regulatory frameworks, including QMS, audits, and authority interactions.
- Ability to translate regulatory requirements into clear business actions and decisions.
- 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.
- Fluent in English.
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The base pay range for this position is:
$240,000 - $330,000
Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.
