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Senior Regulatory Affairs Specialist
3 months ago
Experis IT ManpowerGroup has partnered with a leading Medical device organization in the Princeton , NJ for a Senior Regulatory Affairs Specialist role to assist their team. This is an on-site role.
Industry: Medical device
Title: Senior Regulatory Affairs Specialist
Pay Rate:$80-100/hr on W2
Location: Princeton, NJ ( Onsite 100% )
Duration:12 months Contrcat with possible extension or hiring
Job Description:
IVD Devices EXP in Regulatory Affairs
Exp with US 510K Submission in the last 5 years
Writing submissions with Cross Functional Teams
Excellent Technical Writing Skills
Good Communication skills
Technical Writing Examples would be preferred
Responsible for compiling and maintaining US 510k submission and EU IVDR Technical File.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures under the quality system.
Core job responsibilities for this role may include:
•Compile, prepare, and review regulatory submission to US and EU.
•Anticipate regulatory obstacles and emerging issues throughout the product submission
cycle and develop solutions with other members of regulatory and related teams
•Provide regulatory input for responsible countries/region for product lifecycle planning
•Monitor applications under regulatory review, and communicate application progress to internal stakeholders
•Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
•Utilize technical regulatory skills to propose strategies on complex issues
•Identify emerging issues for responsible countries/region
•Assess the acceptability of quality, preclinical and clinical documentation for submission filing
•Provide registration impact assessment in responsible countries/region for design changes
•Provide strategic input and technical guidance on regulatory requirements to
development teams
•Ensure external communications for regulatory purposes meet regulations
SUPERVISORY / MANAGEMENT RESPONSIBILITIES:
Individual provides leadership without direct authority (i.e., project leader).
Individual may provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments.
