Regulatory Affairs manager job Raritan New Jersey
Regulatory Affairs manager job Raritan New Jersey
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Regulatory Affairs manager Job



Employer Name: SpiderID: 8375465
Location: Raritan, New Jersey Date Posted: 1/30/2019
Wage: $58/hr Category: Science/Research
Job Code: 50
Number Of Openings: 1

Job Description:
Regulatory Affairs manager needs 8 years’ experience developing and executing Regulatory strategies for 510(k) and BLA products
Regulatory Affairs manager requires:
 Bachelor’s degree in a Scientific or related Discipline is required, BSMT is a plus
 knowledge of US FDA 21 CFR 200, 300, 600, and 800 series and a working knowledge of EU
 International Regulations and relevant guidance for US FDA Software containing Medical Devices, IVDs, and Biologics required.
 10-20% travel, domestic
 Project management skills
 In Vitro Diagnostic Medical Device experience

Regulatory Affairs manager duties:
 Responsible for interpreting US FDA regulatory requirements, determining regulatory strategy for IVD Biologics and Device products with International Regulatory knowledge, a
 serve as the point of accountability for project level and product regulatory strategies across the full product lifecycle.
 Independent and collaborative to execute activities related to maintaining compliant regulatory status for marketed products including change management, biological deviation reports, annual reporting, labeling review, audit support, develop and update procedures,


Job Requirements:
Regulatory Affairs manager needs 8 years’ experience developing and executing Regulatory strategies for 510(k) and BLA products
Regulatory Affairs manager requires:
 Bachelor’s degree in a Scientific or related Discipline is required, BSMT is a plus
 knowledge of US FDA 21 CFR 200, 300, 600, and 800 series and a working knowledge of EU
 International Regulations and relevant guidance for US FDA Software containing Medical Devices, IVDs, and Biologics required.
 10-20% travel, domestic
 Project management skills
 In Vitro Diagnostic Medical Device experience

Regulatory Affairs manager duties:
 Responsible for interpreting US FDA regulatory requirements, determining regulatory strategy for IVD Biologics and Device products with International Regulatory knowledge, a
 serve as the point of accountability for project level and product regulatory strategies across the full product lifecycle.
 Independent and collaborative to execute activities related to maintaining compliant regulatory status for marketed products including change management, biological deviation reports, annual reporting, labeling review, audit support, develop and update procedures,


Job Criteria:
Start Date: ASAP
Position Type: Full-Time Temporary
Years of Experience Required: 8
Education Required: Bachelors
Overnight Travel: None
Vacation Time: No Paid Vacation


Contact Information:
Contact Name: Ella Francis Company Type: Recruiter
Company: Global Channel Management, Inc.
City: Austell
State: Georgia
Zip: 30106
Web Site: https://www.globalchannelmanagement.com/

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