Regulatory Affairs Director - Washington United States - 44661



JOB DESCRIPTION

Job #: 44661
Title: Regulatory Affairs Director
Job Location: , Washington - United States
Employment Type:
Salary: contact recruiter for details
Employer Will Recruit From: Nationwide
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?


Client is globally renowned IVD product manufacturing company has its presence in Irvine, CA and they are now expanding to East coast in DC area.
They specializes in IVD diagonostic products like PCR test kits, Rapid test kits, etc.
Great opportunity to build and spearhead their entire RA division in US. 

JOB DESCRIPTION

<Specific Duties and Responsibilities>:

• Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy

• Timely compile materials for license renewals, updates and registrations

• Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners

• Review labeling and labels for compliance with regulatory requirements

• Provide the regulatory reviews of customer complaints and define the regulatory reportability

• Responsible for timely registration of the facility

• Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products

• Actively participate in evaluation of regulatory compliance of document / product changes

<Core Job Responsibilities>:

• Complete submissions to US FDA regulatory entities.

• Create and maintain product US FDA technical files.

• Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.

• Supervise Regulatory Affairs consultants as required.

• Other duties as assigned

 

QUALIFICATIONS

<Requires

• BA degree in a science or related field

• At least 15 years relevant experience within the regulatory affairs discipline for Regulatory Affairs Director and at least 5 years for Junior(or Senior) Regulatory Affairs Specialist.

• Knowledge of US IVD regulatory requirements

• Experience with IVD is mandatory

• Former experience at FDA or IVD manufacturer(Cepheid, Abbott, Roche and so on) is a plus

 

 

Education:
University - Bachelor's Degree/3-4 Year Degree

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