Experis IT ManpowerGroup has partnered with a leading Medical device organization in the Lake Forest, IL for a Regulatory Affairs Associate role to assist their team. This is an on-site role.
Industry: Medical device
Title : Regulatory Affairs Associate
Pay Rate: $30-33/hr on W2
Location: Lake Forest, IL
Duration: 12 months contract with possible extension or hiring
Job Description :
•Provide regulatory input to product lifecycle planning.
•Evaluate proposed software, hardware and manufacturing changes for regulatory filing strategies.
•Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
•Participate in risk benefit analysis for regulatory compliance.
•Determine and communicate submission and approval requirements.
•Assist in preparation and review of regulatory submission to authorities.
•Assist compliance with product postmarketing approval requirements.
•Submit and review change controls to determine the level of change and consequent submission requirements.
•Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and on-time delivery of project milestones. Establishes priorities of work assignments.
•Establishes and cultivates an extensive network of support to facilitate completion of assignments.
•Participates in determining goals and objectives for projects.
•May organize and lead team meetings.
•Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.
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