Senior Associate I, Regulatory Affairs Strategy
3 days ago
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. We foster an inclusive culture and are looking for diverse, dedicated 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. WHAT YOU'LL BRING TO ALCON: Key Requirements/Minimum Qualifications : Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs) The ability to fluently read, write, understand, and communicate in English. 2 Years of Relevant Experience How you can thrive at Alcon : Benefit from working in a highly collaborative environment. Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more Travel Requirements: 10% Relocation assistance: No Sponsorship available: No
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Regulatory Affairs Associate I
5 days ago
Lake County, United States Katalyst HealthCares & Life Sciences Full timeJob Description:The Regulatory Affairs Associate will be responsible for managing, authoring, and compiling Chemistry, Manufacturing, and Control (CMC) sections of regulatory submissions for marketed product variations, including Class III implantable medical devices. This position involves coordinating cross-functional activities to ensure timely and...
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Lake Forest, United States Alcon Full timeManager II, Regulatory Affairs Strategy For Digital HealthAt 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...
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Lake Forest, CA, United States Alcon Full timeManager II, Regulatory Affairs Strategy for Digital Health 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...
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Lake Forest, California, United States Alcon Full timeManager II, Regulatory Affairs Strategy for Digital HealthAt 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...
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Associate Director, Regulatory Affairs
3 weeks ago
Salt Lake City, United States Utah Staffing Full timeAssociate Director Regulatory AffairsSumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early-...
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Regulatory Affairs Specialist
3 weeks ago
Salt Lake City, United States Utah Staffing Full timeRegulatory Affairs SpecialistAn RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates) through...
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Salt Lake City, UT, United States Bausch + Lomb Full timeBausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. Our comprehensive portfolio of over 400 products is fully...
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Director, Regulatory Affairs
2 weeks ago
Salt Lake City, UT, United States Becton Dickinson & Company Full timeJob Description Summary Job Description We are the makers of possible! BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of...
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Global Regulatory Affairs Principal Specialist
3 weeks ago
Lake Forest, CA, United States Alcon Full timeJob Title: Global Regulatory Affairs Principal Specialist Location: Fort Worth, TX, Johns Creek, GA, or Lake Forest, CA Summary of Position: Alcon is looking to hire a Global Regulatory Affairs Principal Specialist to join our Regulatory Affairs team in Fort Worth, TX, Johns Creek, GA or Lake Forest, CA location. You will be responsible for developing global...
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Regulatory Affairs Specialist
3 days ago
Salt Lake City, UT, United States Biomerieux Full timeDescription Position Summary: An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates)...
