Director, Quality and Regulatory Affairs, Digital Health

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As DIRECTOR, QUALITY AND REGULATORY AFFAIRS, DIGITAL HEALTH, supporting our REGULATORY AFFAIRS, you will be trusted to lead the Alcon Quality and Regulatory Affairs team responsible for the development and maintenance of Alcon Digital Health (DH) products (e.g., software as a medical device [SaMD], software in a medical device [SiMD], and non-device software products) in LAKE FOREST, CALIFORNIA, US OR FORT WORTH, TEXAS.

• Operate as the primary point of contact for Quality and Regulatory Affairs representation for DH product development and maintenance of marketed products and will oversee the end-to-end Regulatory Affairs and Quality strategies for DH products.

• Oversees and monitors aspects of the Quality Management System for DH-related processes ensuring that the Quality Management System complies with quality and regulatory standards. This Includes:

  • Accountability for compliance with design control requirements for DH medical device products and development requirements for non-device software products;

  • Accountability for risk management activities to identify, assess, and mitigate potential quality risks associated with DH products;

  • Accountability for ensuring DH usability studies and clinical trials adhere to regulatory requirements, industry standards, and internal policies related to GCP.

  • Accountable for QRA-related operational activities for life cycle management of DH products, including change control, CAPA, and post-market surveillance.

  • Establishing key performance indicators (KPIs) and quality metrics to monitor and report on the effectiveness of the QMS;

  • Support for internal and external audits for DH products.

• Oversees the development and implementation of regulatory strategies across the DH development portfolio, marketed products and/or line extensions through development, registration and approval, including post-approval commitments and life cycle management.

• Anticipates and provides assessments of changing regulations and guidance, and identifies any needed changes to internal DH policies and processes.

• Ensures high-quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans for DH products.

• Directs the development of DH submission packages that are clear, concise, and complete to facilitate regulatory reviews/approvals.

• Ensures high-quality and professional interactions with Health Authorities (HAs) globally, including participation in key formal and informal HA contacts as required.

• Leads and supervises assigned regulatory liaisons including performance management, in collaboration with the global line functions.

• Recruits, trains, and manages a high-performing QRA Digital Health team.

• Bachelor's Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)

• The ability to fluently read, write, understand and communicate in English

• 10 Years of Relevant Experience

• 6 Years of Demonstrated Leadership

• Work hours: Monday through Friday - Business Hours

• Travel Requirements: 15% to 20%

• Relocation assistance:No

• Sponsorship available: No

• 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.

• Knowledge of compliance requirements with 21 CFR 820, EU MDR, MDSAP, ISO 13485, 14971, 27001, IEC 62304, 82304, AAMI TIR45, cGMP 21 CFR 820, HIPAA, GDPR, data integrity.

• Expert knowledge of US FDA and ISO requirements for Quality Systems and GCP.

• Continuous improvement certification, certified auditor, ASQ certifications are preferred.

• Collaborate with teammates to share standard processes and learnings as work evolve

• See your career like never before with focused growth and development opportunities

• Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes 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. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.