Senior Director of Design Control

hace 4 semanas

Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo
Senior Director, Design Control- Cambridge MA- Hybrid

At ICON, we're committed to advancing and improving patients' lives through innovative clinical development solutions. As a Senior Director of Design Control, you'll play a critical role in leading our IVD design control team and driving excellence in quality and compliance.

Key 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.

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.

Equal Opportunity Employer:

  • ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment.

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