Merck
Executive Director, Device Quality & Regulatory
Merck, Salem, Oregon, us, 97308
Merck Executive Director, Device Quality & Regulatory Salem, Oregon Apply Now
The Executive Director, Device Quality & Regulatory will play a pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors and other innovative drug delivery systems associated with combination products. This role ensures the highest standards of device quality throughout the product lifecycle, from design and development to commercialization. The individual will also manage the regulatory Chemistry, Manufacturing, and Controls (CMC) content for global submissions, ensuring adherence to international regulatory requirements.Primary Responsibilities:Leadership and Personnel Management:
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.
Device Quality Oversight:
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.
Regulatory CMC Oversight:
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.
Compliance and Continuous Improvement:
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.
Strategic Contributions:
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.
Education:Bachelor’s Degree in Engineering, Life Sciences, or a related fieldMaster’s or Ph.D. preferredRequired Experience and Skills: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.Preferred Experience and Skills: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.
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The Executive Director, Device Quality & Regulatory will play a pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors and other innovative drug delivery systems associated with combination products. This role ensures the highest standards of device quality throughout the product lifecycle, from design and development to commercialization. The individual will also manage the regulatory Chemistry, Manufacturing, and Controls (CMC) content for global submissions, ensuring adherence to international regulatory requirements.Primary Responsibilities:Leadership and Personnel Management:
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.
Device Quality Oversight:
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.
Regulatory CMC Oversight:
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.
Compliance and Continuous Improvement:
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.
Strategic Contributions:
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.
Education:Bachelor’s Degree in Engineering, Life Sciences, or a related fieldMaster’s or Ph.D. preferredRequired Experience and Skills: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.Preferred Experience and Skills: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.
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