Quality Oversight of Change Management/International Support for Contact Lens and Surgical
Provide support for Change Management Process including governance and QPI metric reporting
Provide International Support for regional regulatory requests such as adding new products, registration renewal, registration support
Provide direct support for Change Management including regulatory assessments, change governance, Monthly QPI Metric reporting.
• Facilitate Global Regulatory Assessments for the North America
Operations using a structured process and through engagement
with our international regulatory professionals and international
• Primary contact Idriver for US regional changes. Support site
Change Implementation Managers to drive changes that affect ex-
• Serve as the North American focal point for change requests of the
various regions, along with requests for information supporting
global product registrations.
• The role will include the following activities with respect to Change
- processing changes from the sites and external sources to the
COC for review
- provide management with appropriate measures of system
- identify and resolve situations where regionally approved changes
lose momentum or become dormant
• Work within a peer team structure to develop the underlying
processes for this group including performance measures. Based
upon system feedback drive continual improvement in associated
• Help solidify and strengthen the Global Change Management
support network and process through proactive engagement with
international peers and key stakeholders. Provide training as
required to both international and domestic groups in support of the
Provide direct support for international requests regarding registration
maintenance, renewal, addition of new products or SKU's. These activites
• Providing single point of contact for the regional informational
requests for registration support and country specific requirements
• Create informational repository for regional
Bachelor's Degree BS in engineering or scientific discipline (Chemistry, Biology, Microbiology or related technical field).
Experience in Regulatory Affairs is required.
3+ years experience in Medical Device or Pharmaceutical Industry.