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Regulatory Affairs Associate

Remote
Shift: M-F 8AM-5PM CST
Contract: 12 months duration

Automated Systems, Inc is seeking a Regulatory Affairs Associate who will be responsible for the global coordination and the preparation 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 products.

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




Requirements

Education and Experience Requirements:
• 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 (not mandatory) preferably within a healthcare environment
Top skill requirements:
-Familiar with USA and OUS device regulations (specifically EU device regulations)
-Experience with RA strategy development
-Experience with working with Cross functional team members
-Experience with interaction with external Regulators (FDA, TUV)
-Experience with working with medical devices
-Knowledge of Excel, Word, Power Point