Senior Director, Design Control- Cambridge MA- Hybrid SENIOR DIRECTOR, DESIGN CONTROL - CAMBRIDGE MA - HYBRID
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.
Responsibilities: Lead and manage the IVD design control team, providing direction, support, and mentorship. Develop and implement strategic plans for IVD design control activities in alignment with company objectives and ensure compliance with applicable regulations and standards. Collaborate with Regulatory Affairs and provide support during internal and external audits and inspections. Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, IVDR, CLIA, and other applicable standards. Establish and maintain IVD design control procedures, templates, and tools. Integrate robust ISO14971 risk management processes into design and development phases. Oversee the development of design history files (DHFs) and technical files (TFs) to ensure completeness and accuracy. Lead IVD design control activities for new product development projects. Coordinate with cross-functional teams to ensure cohesive and compliant product development. Monitor project timelines, budgets, and resource allocation. Drive periodic improvement initiatives to enhance IVD design control processes. Implement lessons learned from post-market surveillance to improve IVD design control practices. Develop and deliver training programs on IVD design control requirements. Promote a culture of quality and compliance within the organization. Expected travel needs approximately 25%. Qualifications: Minimum of 10 years of experience in design control within the medical device or clinical laboratory industry. PhD in a science-related field preferred. In-depth knowledge of FDA regulations, ISO 13485, ISO14971, IVDR, CLIA, and other relevant standards. Experience with Laboratory Developed Tests (LDTs) and understanding of their regulatory requirements. Strong project management skills with experience leading cross-functional teams. Proven leadership experience with the ability to manage and mentor a team. Strong interpersonal and communication skills. Ability to multitask and possess strong creative thinking and problem-solving skills. Benefits of Working at ICON: Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent. We offer competitive salary packages, annual bonuses, and a range of health-related benefits.
ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment.
If you need a reasonable accommodation for any part of the application process, please let us know.
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