Executive Director, Device Quality & Regulatory

$243,500 - $383,300/Yr

Merck KGaA Darmstadt Germany - Springfield, IL

Full-time - Executive

Onsite - Springfield, IL

Chemical Manufacturing

About the position

The Executive Director, Device Quality & Regulatory at Merck will lead the quality assurance and regulatory CMC for complex medical devices, ensuring adherence to the highest standards throughout the product lifecycle. This role involves overseeing a high-performing team, managing regulatory submissions, and driving continuous improvement in device quality and compliance.

Responsibilities

• Lead and manage a high-performing team of quality and regulatory professionals.
• Provide strategic direction, mentorship, and development opportunities to personnel.
• Foster a collaborative environment between cross-functional teams including device development, device technology, procurement, supply chain and manufacturing.
• Establish clear performance goals and metrics for the team to drive excellence.
• Oversee the quality assurance of complex devices, such as auto-injectors and other complex drug delivery systems.
• Ensure adherence to quality standards and regulatory requirements throughout the product design, development, and manufacturing processes.
• Implement risk management principles (ISO 14971) in design and development to ensure safe and effective product performance.
• Collaborate with engineering, R D, and manufacturing teams to ensure quality integration into product design and development processes (Design Control per ISO 13485, QMSR, Part 4).
• Lead quality oversight of product validation, verification, and risk mitigation activities.
• Lead the preparation and submission of high-quality regulatory CMC device content for global submissions, including IND, NDA, BLA, and MAA applications.
• Ensure that regulatory submissions meet the requirements of FDA, EMA, and other health authorities, while keeping up with the latest regulatory guidelines and trends.
• Collaborate with global regulatory teams to align strategies and ensure submission readiness in all key markets.
• Engage with regulatory agencies as needed, including participation in meetings, providing justifications, and responding to queries.
• Develop and implement continuous improvement strategies for device quality and regulatory processes.
• Monitor and ensure compliance with global regulations and quality standards, including Part 4, QMSR, ISO 13485, and other applicable standards.
• Support internal audits and inspections, manage non-conformances, and drive root cause analysis and corrective action processes.
• Stay updated on emerging regulations and industry trends affecting device quality and regulatory affairs.
• Serve as a key member of the device quality & regulatory leadership team, contributing to the strategic direction of the company's product pipeline and regulatory strategy.
• Drive operational excellence initiatives that improve quality, compliance, and organizational efficiency.
• Liaise with external partners, suppliers, and regulatory bodies to support product launches and lifecycle management.

Requirements

• 10+ years of experience in device quality, device regulatory affairs, or a related field within the pharmaceutical, biotechnology, or medical device industries.
• Demonstrated expertise in the design/development (QA oversight), and/or regulatory submission of complex medical devices, including auto-injectors or other drug delivery systems.
• Experience working with device component and sub-assembly suppliers.
• Strong knowledge of global quality system and regulatory requirements for combination products, including FDA, EMA, and other health authority guidelines.
• Strong understanding of ISO 13485, ISO 14971, QMSR, Part 4, and other relevant standards.
• Proven track record in managing teams and leading cross-functional collaboration.
• Excellent communication, leadership, and problem-solving skills.

Nice-to-haves

• Experience working with combination products or medical devices from both quality and regulatory perspective.
• Experience developing and commercializing auto-injectors, pen-injectors from both quality and regulatory perspective.
• Regulatory Affairs Certification (RAC) or equivalent.
• Quality certifications such as CQA, CQE.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days