Senior Director, Design Control- Cambridge MA- Hybrid

5 days ago


Cambridge, Massachusetts, United States ICON Strategic Solutions Full time
Senior Director, Design Control

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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