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Global Regulatory Affairs Principal Specialist
2 days ago
Job Title: Global Regulatory Affairs Principal SpecialistLocation: Fort Worth, TX, Johns Creek, GA, or Lake Forest, CASummary 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 regulatory strategy for new product development, directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports, providing strategic product direction to teams on interaction and negotiating evidence with regulatory agencies, interacting and negotiating with regulatory agency personnel in order to expedite approval of pending registration and answer any questions.Key Responsibilities:Develops global regulatory strategy for new product development.Directs submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports to support US, EU and Canada markets.Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answer any questionsServes as a regulatory liaison on the project team throughout the product lifecycle.Participates in one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan.Ensuring pre-clinical and clinical trial designs meet regulatory requirementsEnsuring rapid and timely approval of new medical devices and continued approved status of marketed medical devicesServing as regulatory representative to marketing or research project teams and government regulatory agencies.Providing advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.Coordinating, reviewing and potentially preparing reports for submission In some organizations, may coordinate and maintain reporting schedules for new medical devices and marketed products notices.Provides support as needed for non-project related "regulatory excellence" activities.Ensures awareness of and compliance with global regulatory requirements and adherence to internal policies and processes.In a timely manner, provides solutions to a range of regulatory issues and has the freedom to act independently to execute.Proactively track and support regulatory intelligence activities related to the Alcon medical device portfolio.Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.Key Requirements/Minimum RequirementsBachelor's Degree or Equivalent years of directly related experience (or high school +13 yrs;Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)The ability to fluently read, write, understand, and communicate in English5 Years of Relevant ExperienceWork hours: 40 hoursTravel Requirements: 10% domestic or intl.Relocation assistance: NoSponsorship available: NoPreferred Qualifications/skills Experience:FDA medical device regulations and EU MDR experience preferred.
