Coordinator, Regulatory Affairs

Nuvasive San Diego , CA 92140

Posted 1 week ago

Job Description:

  • Coordinate with outside suppliers to ensure ordering, receipt, and implementation of new and revised labeling.

  • Manage data for GUDID and EUDAMED databases

  • Coordinate review, obtain internal approvals and ensure implementation of new and revised labeling in accordance with applicable regulations and policies.

  • Manage internal documentation requirements including change controls (via SAP), specifications, BOMs, translations, and artwork/images.

  • Participate in product master data process (e.g., MMR) to ensure that all product data is consistent from the source systems to the final product labeling including multiple language translations.

  • Liaise regulatory, marketing, supply chain, engineering, operations, and legal in labeling development process.

  • Manage product image glossary, branded artwork, translations and product description databases.

  • Manage translation supplier projects, priorities, budget, and delivery timelines.

  • Responsible for proofreading and departmental QC for all product descriptions and labeling content.

  • Maintain website content and databases for all publically available labeling and internal only content.

  • Creation and revision of all Inventory IFUs and electronic IFUs

  • Routing of all Inventory IFUs and electronic IFUs in SAP

Basic Qualifications

  • Experience with SAP and Microsoft Office (Excel, Word and PowerPoint)

Preferred Qualifications

  • Project Management

NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran status and will not be discriminated against on the basis of disability. The "EEO is the Law" poster options are available

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Coordinator, Regulatory Affairs