SENIOR REGULATORY AFFAIRS SPECIALIST - Long Island, NY - Farmingdale, New York United States - 19860



JOB DESCRIPTION

Job #: 19860
Title: SENIOR REGULATORY AFFAIRS SPECIALIST - Long Island, NY
Job Location: Farmingdale, New York - United States
Employment Type:
Salary: $100,000.00 - $120,000.00 - US Dollars - Yearly
Employer Will Recruit From: Nationwide
• 10 + years of experience in drug or medical device regulatory affairs preferred.
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?


[None Listed]

JOB DESCRIPTION

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

 

QUALIFICATIONS

SENIOR REGULATORY AFFAIRS SPECIALIST - Long Island, NY

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

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