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Senior Global Regulatory Affairs Specialist
Apple & Assoc. Inc
 
Job Location: Boulder, CO

Senior Global Regulatory Affairs Specialist

The Senior Global Regulatory Affairs Specialist is responsible for developing strategies for worldwide governmental approval to introduce new products (Class II & III) to market, maintain existing products, provide advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with the agencies. In addition, this position also assists with the training of other regulatory affairs associates and provides work direction on projects of large scale with significant business impact.

Senior Global Regulatory Affairs Specialist Responsibilities:

  • Team with business unit Regulatory Affair Specialists and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers, and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
  • Prepare FDA submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release. Review significant product submissions with manager and negotiate submission issues with agency personnel.
  • Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status.
  • Review only significant submission decisions/content issues with manager.
  • Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
  • Support regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed.
  • Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
  • Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.
  • Provide feedback and on-going support to product development teams for regulatory issues and questions.
  • Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.
  • May mentor or supervise other RAS, as directed by manager.

Senior Global Regulatory Affairs Specialist Requirements:

  • Bachelor’s degree
  • 4+ years of experience in regulatory affairs or the medical device industry with Bachelor’s degree OR
  • 3+ years of experience in regulatory affairs, or the medical device industry with engineering degree and Master's degree
  • Experience working with medical device or pharmaceutical regulatory submissions.

Senior Regulatory Affairs Specialist Nice To Have:

  • 6+ years medical device industry experience
  • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
  • Effective interpersonal skills
  • Effective team member
  • Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
  • Ability to effectively manage multiple projects and priorities.
  • Proficient computer skills
  • Experience with Class II/III medical devices (510(k), PMA, IDE)
  • Experience performing advertising and promotion reviews for medical devices
  • Product development experience
  • Clinical or statistical experience
  • Experience with FDA and international regulatory agency requirements, ISOIGHTF standards
  • Project management skills




How To Apply:
You will be directed to another website for application instructions.
 
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