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Job Field: Legal 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 SpecialistLocation: United States-California-Aliso Viejo SiteJob Number:_00007947The Surgical Regulatory Affairs Specialist - Global Expansion is responsible for Rest of World (ROW), non-US/EU, registrations for surgical devices as assigned. Products include IOLs, Inserters, OVDs, Equipment, Instruments and Solutions. The incumbent is responsible for providing Regulatory Affairs support under direct supervision of senior regulatory professionals supporting regulatory authorizations to market medical device products in global markets. This position involves the collection and collation of materials required for various country submissions. Position may support facility inspections and participate in other regulatory support activities as required. The position involves interfacing with domestic and international Bausch & Lomb functions (Research and Development, Manufacturing, Legal Counsel, Quality Clinical Research, Marketing and Commercial Strategy). The position acts as a liaison between RA Managers and global B & L regulatory staff to communicate technical product information for product approvals in the preparation of product submissions and license renewals, and daily maintenance of business issues.Essential Duties and Responsibilities* Responsible for obtaining and maintaining ROW approvals for product areas as assigned* Responsible for proactively supporting and executing on strategies for all ROW countries and 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 Plans* Reviews 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:

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Not stated