Digital Health Quality and Regulatory Affairs Director

4 weeks ago


Lake Forest, California, United States Alcon Full time
Job Summary

Alcon is seeking a highly skilled Digital Health Quality and Regulatory Affairs Director to lead our Quality and Regulatory Affairs team responsible for the development and maintenance of Alcon Digital Health products. The ideal candidate will have a strong background in quality and regulatory affairs, with experience in digital health products and software application development.

Key Responsibilities
  • Oversee the end-to-end Regulatory Affairs and Quality strategies for Digital Health products, ensuring compliance with quality and regulatory standards.
  • Develop and implement regulatory strategies across the Digital Health development portfolio, marketed products, and line extensions.
  • Anticipate and provide assessments of changing regulations and guidance, and identify any needed changes to internal Digital Health policies and processes.
  • Lead and supervise assigned regulatory liaisons, including performance management, in collaboration with the global line functions.
  • Recruit, train, and manage a high-performing Quality and Regulatory Affairs Digital Health team.
Requirements
  • Bachelor's Degree or Equivalent years of directly related experience.
  • The ability to fluently read, write, understand, and communicate in English.
  • 10 Years of Relevant Experience.
  • 6 Years of Demonstrated Leadership.
Preferred Qualifications
  • Demonstrated quality and regulatory experience working on Digital Health products and software application development and life cycle management.
  • Experience with Technical scientific writing and regulatory submissions for software.
  • Deep understanding of SaMD, SiMD, AI/ML, cybersecurity, interoperability, and other Digital Health concepts.
About Alcon

Alcon is a global leader in eye care, driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow careers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Digital Health Quality and Regulatory Affairs Director, you will be trusted to lead our Quality and Regulatory Affairs team and make a significant impact in the lives of our patients and customers.

Alcon provides a robust benefits package, including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more. We are an Equal Opportunity Employer and participate in E-Verify. We take pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.



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