Farmingdale NY, United States
$90,000 - $120,000
over 1 year ago
Senior Regulatory Affairs Specialist
Located in Long Island, the company specializes in the development and commercialization of ultrasonic surgical devices for neurosurgical, spinal, advanced wound care, and general surgery procedures. Our portfolio of products are all based upon the unique properties of ultrasound and its ability to differentiate hard and soft tissue for different clinical requirements. A fast-growing global business, they operates in over 45 countries and is a recognized leader in advanced surgical tools offering unprecedented safety, speed, and precision.
In this role, the responsibilities of Regulatory Affairs Specialist/Senior will 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 American and the Pacific Rim.
Essential functions include:
• Ensure timely preparation of all required documents for US and International facility registrations.
• Liaison activities between global regulatory agencies and their European representatives.
• Facilitate 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 American and the Pacific Rim.
• Facilitate 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:
- Design Files, Risk Management, Design Verification and Validation, Technical Files, Global Labeling Standards, Biocompatibility, EtO Sterilization Validation, Generate and assist in composing 510k's
• Facilitates compliance with global electrical safety requirements including, without limitation, UL 60601 and EIC 60601 Standards.
• 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 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.