Regulatory Affairs Associate - Entry Level

With our medical device client, you would be responsible for assisting the team with regulatory information. This position requires basic knowledge and understanding of medical device industry and technical concepts. May perform some or all of the following functions, depending upon their specific assigned focus.
Principal Duties and Responsibilities
  • Coordinate and assist in the preparation of technical documentation for use in regulatory submissions worldwide •
  • Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
  • Assist in the development and review of departmental work instructions, submission templates and/or training materials
  • Assist in the review of labeling for compliance with applicable regulations
  • Assist in the review of advertising and promotional items
  • Follows RA policies and procedures
  • Miscellaneous administrative RA responsibilities as assigned
Expected Areas of Competence
  • Strong writing and communication skills
  • Strong interpersonal skills
  • Versatility, flexibility, and willingness to work with changing priorities •
  • Strong organizational, problem-solving and analytical skills •
  • Affinity for details • Ability to work with rapid changes
  • Ability to learn regulations pertinent to medical devices
  • Ability to learn basics of medical device regulations
  • Ability to handle multiple projects and meet deadlines, working closely with RA Specialists and Managers
  • Basic computer skills, including Microsoft Office Suite
Education/Experience Requirements
  • A degree in life sciences, technical/engineering or related field, or non-US equivalent required. Other degrees may be considered.
  • Regulatory Affairs intern experience preferred
Apply for this Position
  • Accepted file types: pdf, doc, docx.