Pyramid Consulting Round Lake , IL 60073
Posted 2 days ago
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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Pyramid Consulting