Senior Regulatory Affairs Specialist - 510K REQUIRED Not right for you? We've got others

Salary:
$100,000 - $120,000
Location:
Farmingdale, New York
Posted:
March 26th 2019
Minimum Degree:
Bachelor
Relocation Assistance:
Available
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SENIOR REGULATORY AFFAIRS SPECIALIST - Long Island, NY
Ensures timely preparation of all required documents for US and International facility registrations.
Liaison activities between global regulatory agencies and company’s European representatives.  
Facilitates compliance to requirements and establish documentation to support global premarket clearance in accordance with FDA 510k, EEC 93/42 CE Marking Essential Requirements, Health Canada License Applications, and product registration requirements in South America and the Pacific Rim.  
Facilitates compliance to ISO 13485 quality systems and 21 CFR Part 820 good manufacturing practice requirements especially in the systems for Design Control and Change Control.
POSITION QUALIFICATIONS
BA/BS degree in a science or engineering preferred.  
10 + years of experience in drug or medical device regulatory affairs preferred.  
Knowledge of global premarket clearance/product license/product registration requirements. 
Working knowledge of GMP 21 CFR 211 and ISO 13485 guidelines
Knowledge of electromechanical safety requirements preferred. 
Ability to work independently as well as in a cross functional team environment, including R&D, Manufacturing, Quality Assurance and Engineering.
Relocation available

 



Requirements:

SENIOR REGULATORY AFFAIRS SPECIALIST - Long Island, NY

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