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 a Notified Body Liaison, Quality Assurance Associate Director , you will be responsible for the coordination and management of the Quality Management System change with the Notified Body to support MDD and MDR changes activities, with demonstrated initiative to working independently. In this role a typical day will include:
Leads, prioritizes and manages Alcon Corporate QMS Change Notification Submission Management across the Franchises to support an optimized process ensuring Alcon business needs are met by the Notified Body, and working within the NB Liaison Team to ensure appropriate surveillance scopes are considered in a timely manner.
Pro-actively interacts directly with the Sites to identify potential QMS Certificate impact arising from LCM CNs, thereby providing high quality regulatory support and driving right first time submissions.
Responsible for the management of the NB Audit Schedule and for the management of the appropriate communication and coordination between Corporate, Sites and NB.
Responsible for the development and management of Notified Body Quality System Certificate structure and content (MDD and MDR). Provides training and guidance to sites to ensure accurate, compliant QS activity scopes.
Responsible for the revision controlled management of QS Certificate impacting Site information (i.e. not limited to; Scopes, Addresses. Company Profile).
Develops and / or Optimizes in-house tracking tools to track timely QMS CN submissions, and NB Surveillance Audit Schedules.
Collaborates with the MDR PMs, GRA strategists and cross- functional teams to support MDRSub. Strategy and actively lead and drive implementation timelines from a QMS perspective.
Responsible for the NB QMS Budget timely generation and management.
Act as Local Actor Administrator (LAA) or Local User Administrator (LUA) for EUDAMED activities.
Provides solutions to a range of QMS NB / Site queries and has the freedom to act independently to execute.
Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.
Develops documents that are clear, concise, and complete to facilitate reviews/approvals.
Develops and manages global regulatory strategies to maximize the value of the products/projects.
What You’ll Bring to Alcon :
Key Requirements/Minimum Qualifications:
Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
The ability to fluently read, write, understand, and communicate in English.
7 Years of Relevant Experience
5 Years of Demonstrated Leadership
Considering candidates from Europe locations.
Preferred Qualifications :
PhD + 1years of related experience (if people management position)
3 years demonstrated leadership (if people management position)
How You Can Thrive at Alcon :
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, and much more!
Travel Requirements: 10%
Relocation assistance: No
Sponsorship available: No
#LI-DNI
