Senior Regulatory Affairs Specialist - Remote / Telecommute

Cynet systems Inc
Irvine
2 months ago
Applications closed

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Responsibilities

  • Participate in assessing and collating regulatory impact and developing regulatory strategy.
  • Collaborate and approve change requests/change notifications.
  • Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and labeling content.
  • Other incidental duties assigned by Leadership.

Additional Skills

  • Coursework, seminars, and/or other formal government and/or trade association training required.
  • Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel.
  • Good written and verbal communication skills and interpersonal relationship skills.
  • Good problem-solving, organizational, analytical and critical thinking skills
  • Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
  • Solid knowledge and understanding of global regulatory requirements for new products or product changes.
  • Strict attention to detail.
  • Ability to interact professionally with all organizational levels.
  • Ability to manage competing priorities in a fast paced environment.
  • Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects.
  • Ability to build productive internal/external working relationships.

Education and Experience

  • Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry).
  • 5-7 years of experience required.


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