SURGICAL REGULATORY AFFAIRS MANAGER
Job Field: Office Jobs
Location: Aliso Viejo Site, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>Title: Surgical Regulatory Affairs ManagerLocation: United States-California-Aliso Viejo SiteJob Number:_00007883This position is responsible for obtaining and maintaining international approvals for Surgical products. The incumbent may also lead regulatory activities for some product development team projects. Incumbent has responsibility for direct submissions and maintenance of approvals with Heath Canada for all Surgical products. This role will have strong emphasis on registrations in emerging markets, e.g. BRICK countries.Health Canada submissionsProactive ROW submissions in assigned product areas, especially in BRICK countries.Participation in project teams as assignedProcessing Sharepoint requests and ensuring accuracy, appropriateness and completeness of documentationEnsuring global RA assessments are processed and provided to RA Managers for inclusion in project timelinesSupports continuous improvement of department processes through consistency in submission documentationThe Surgical Regulatory Affairs Manager - Global Expansion is responsible for Rest of World (ROW) registrations for surgical devices as assigned. ROW is defined as all countries outside the US and EU member states. Products include IOLs, Inserters, OVDs, Equipment, Instruments and Solutions. The incumbent may participate on certain product development teams to provide regulatory guidance for surgical devices as assigned. The incumbent also manages relevant regulatory strategy components and interactions with Regulatory Authorities for assigned surgical products.Responsible for obtaining and maintaining ROW approvals for product areas as assignedResponsible for direct submissions in Canada for all Surgical ProductsResponsible for proactively supporting and executing on strategies for BRICK countries (Brazil, Russia, India, China and Korea) for product areas as assigned.Responsible for completing global product regulatory assessments for surgical devices as assigned.Liaises with global regulatory counterparts in the collection and collation of documentation required for international submissions and ensures regional requirements are incorporated into Global Regulatory PlansReviews product technical information for accuracy and completeness.Executes product registration support through Sharepoint requests for product areas as assigned.Assure that ROW registration timelines are aligned with Bausch & Lomb
KEY REQUIREMENTS:
Not stated