Global Compliance Associate

Company Name:
ABC Employment Agency of Long Island
JOB TITLE: Regulatory Affairs Specialist/Associate I
The duties and responsibilities of RAQA Specialist/Associate I include the support of activities related to global premarket clearance and design control including, without limitation, in the United States, Canada, European Economic Community, South America and the Pacific Rim.
Ensures timely preparation of all required documents for US and International facility registrations.
Liaison activities between global regulatory agencies and Misonix 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 including, without limitation:
o Design Files
o Risk Management
o Design Verification and Validation
o Technical Files
o Global Labeling Standards
o Biocompatibility
o EtO Sterilization Validation
Facilitates compliance with global electrical safety requirements including, without limitation, UL 60601 and IEC 60601 Standards.
BA/BS degree in a science or engineering preferred.
2-5 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 in a challenging and fast-paced work environment.
Excellent written communication, project management, and analytical thinking skills.
Ability to work independently as well as in a cross functional team environment, including R&D, Manufacturing, Quality Assurance and Engineering.

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