Senior Associate I, Regulatory Affairs Strategy
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About The Position
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 Senior Associate I, Regulatory Strategy joining our Regulatory Affairs team in Lake Forest, CA, you are responsible for providing support in ensuring compliance with all FDA and other U.S. and global regulatory requirements. This position supports internal and global customers to meet corporate submission and registration objectives for timely approval. Work with global partners and support worldwide registrations efforts. Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives. Manages requests from regions and countries, provides responses and requested documentation (CFG's, FSC, certifications, Letter of Authorization, etc.) in a timely manner. Prepares supporting documentation and arrange for legalizations, as required by country regulations. Support communications with US and international affiliates and regulatory personnel. Ensures compliance with global regulatory requirements and adherence to internal policies and processes. Provides high quality regulatory support for assigned products/projects. Develops documents that are clear, concise, and complete to facilitate and maintain registration renewal, tenders, and licenses. Prepare, consolidate, response and follow-up on change assessments for global regulatory strategies. Review and approve labeling to ensure accuracy of content. Maintain a current knowledge of global medical device regulations pertaining to the distribution of products, which include facility registration and device listing. Maintain documentation and a historical record for regulatory submissions. Notarize regulatory registration documents as necessary. Willing to obtain notary license in California.
