USA - Regulatory Affairs Associate I

Immediate need for a talented Regulatory Affairs Associate. This is a 06+ months Contract opportunity with long-term potential and is located in Round lake, IL (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID: 23-06747
Pay Range: $40/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key 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

Key Requirements and Technology Experience:

• 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
• 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
• 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

Our client is a leading Healthcare industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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