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IR

Regulatory Affairs Associate I

Integrated Resources, Inc
🇺🇸 United States
Remote
1 week ago
1 week ago
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Title: Regulatory Affairs Associate I
Location: Skaneateles, NY (100% Remote)
Duration: 08 Months+ Possible Extension
Pay Range: $40-$45/hr
Schedule (flexible)

Description:
  • Responsible for the global coordination and thepreparation of documents/packages for regulatory submissions.
  • In this position you will also review and evaluate technical and scientific data and reports required for submission in support of global client products.
Top three to five technical skill requirements:
  • Familiar with USA and OUS device regulations (specifically EU device regulations).
  • Experience withRA strategy development.
  • Experience with working with Cross functional team members.
  • Experience with interaction withexternal Regulators (FDA, TUV).
  • Experience with working with medical devices.
Essential Duties and Responsibilities:
  • Supports regulatory project plan execution
  • Maintain awareness of regulatory requirements and ensure continued learning.
  • Maintain regulatory files in a format consistent with requirements.
  • Participate as an active team member of project teams as required.
  • Compile and prepare responses to questions from regulatory authorities according to plan.
  • Edit and proofread regulatory documentation.
  • Assist in preparation and review of labeling, SOP’s, and other departmental documents.
  • Compile under supervision regulatory documents for submission.
  • Track status and progress of regulatory documentation.
  • Understand Regulatory Affairs' position in small project teams.
Qualifications:
  • Knowledge of regulations.
  • Scientific knowledge.
  • Administrative and project management skills.
  • Ability to contribute to multiple projects from a regulatory affairs perspective.
  • Ability to multitask and prioritize.
  • Interpersonal and communication skills.
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research).
  • Proofreading and editing skills.
Education and/or Experience:
  • Bachelor’s degree or country equivalent in a relevant scientific discipline.
  • Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification.
  • Regulatory experience preferably within a healthcare environment.

Regulatory Affairs Associate I · Integrated Resources, Inc

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