Senior Director, Design Control- Cambridge MA- Hybrid
5 days ago
At ICON Strategic Solutions, we're committed to advancing and improving patients' lives through innovative clinical development solutions. As a Senior Director, Design Control, you'll play a critical role in leading our IVD design control team and ensuring compliance with regulatory requirements.
Key Responsibilities:
- Lead and manage the IVD design control team, providing direction, support, and mentorship to ensure successful project delivery.
- Develop and implement strategic plans for IVD design control activities, aligning with company objectives and ensuring compliance with FDA, ISO 13485, IVDR, CLIA, and other relevant standards.
- Collaborate with Regulatory Affairs to ensure robust regulatory compliance and provide essential support during internal and external audits and inspections.
- Establish and maintain IVD design control procedures, templates, and tools to ensure efficient and compliant processes.
- 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, ensuring timely and compliant progression through design phases.
- 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.
Requirements:
- 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, including the ability to work independently and efficiently.
Benefits:
At ICON Strategic Solutions, we offer a competitive salary package, annual bonuses, and a range of health-related benefits to employees and their families. We're committed to providing a workplace free of discrimination and harassment, and we're an equal opportunity employer.
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