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Senior RA Specialist

Company: Alcon Vision, LLC-JW
Location: Lake Forest
Posted on: January 10, 2022

Job Description:

Job Title: Senior RA SpecialistLocation: Lake Forest, CA
Summary of Position:Alcon is looking to hire a Senior RA Specialist to join our Global Regulatory Affairs Surgical team in Lake Forest, CA. You will be responsible interpreting regulations as they apply to products, financial processes, and other processes, practices and procedures as well as investigating and resolving compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
Key Responsibilities:

  • Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and that regulatory reporting requirements are met.
  • May develop and implement programs designed to increase employee awareness and knowledge of compliance policies.
  • May audit or evaluate current policies, procedures, and documentation for compliance with government laws and regulations.
  • May include compliance review and approval of promotional materials.
  • May provide input to marketing and/or research and development on new product opportunities as a result of changes in the regulatory environment.
  • May develop and direct compliance training and monitoring programs.
  • Works in close collaboration with internal stakeholders and supports multiple projects.
  • Provides support as needed for non-project related "regulatory excellence" activities.
  • Ensures compliance with global regulatory requirements and adherence to internal policies and processes.
  • Responds to regulatory requests from across the organization in a timely manner.
  • Provides high quality regulatory support for assigned products/projects.
  • Partners with internal stakeholders (e.g., regions) to align on an optimized regulatory strategy in order to achieve business objectives.
  • Develops training programs for internal stakeholders, as needed.
  • Develops documents that are clear, concise, and complete to facilitate reviews/approvals.
  • Demonstrated ability to coordinate and work effectively with multiple stakeholders.
  • Ensures timely, clear communications to internal stakeholders on project status and issues.
  • Serves as role model and embraces corporate Values and Behaviors.
  • Demonstrated good organizational and time management skills, including the ability to work on multiple projects and adhere to timelines.
    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
    • Work hours: 40 hours
    • Travel Requirements: 0%
    • Relocation assistance: No
    • Sponsorship available: No
      Preferred Qualifications/Skills/Experience:
      • Meets individual goals as defined in the annual objectives.
      • Ability to support the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks.
      • Ability to work in a matrixed environment and influence internal partners to achieve desired business outcomes.
      • Strong writing skills in the form of high quality regulatory submission documents.
      • Committed to drive efficiency while maintaining quality.
      • Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.

Keywords: Alcon Vision, LLC-JW, Lake Forest , Senior RA Specialist, Other , Lake Forest, California

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