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 to support internal and external audits and inspections related to design control and regulatory compliance.
- Establish and maintain IVD design control procedures, templates, and tools.
- Ensure robust ISO14971 risk management processes are integrated into the design and development phases.
- Oversee the development of design history files (DHFs) and technical files (TFs) to ensure completeness and accuracy.
- Coordinate with cross-functional teams to ensure cohesive and compliant product development.
- Monitor project timelines, budgets, and resource allocation to ensure projects are completed on time and within budget.
- Drive periodic improvement initiatives to enhance IVD design control processes, efficiency, and product quality.
- Develop and deliver training programs on IVD design control requirements for internal teams.
- Promote a culture of quality and compliance within the organization through regular communication and training.
- 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, good laboratory, and organizational skills.
- Ability to multitask, along with an orientation toward teamwork and leadership.
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 very competitive salary packages, health-related benefits, and retirement plans.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment.
If you need a reasonable accommodation for any part of the application process, please let us know.
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