About us: Network Partners is looking for “best in class”’ RA Specialists to join our team. We are a spirited, high-growth company focused on the success of our clients and our colleagues. We put a new spin on consulting and staffing that allows you to work at a company dedicated to the discipline of Regulatory Affairs while simultaneously working for some of the world’s largest and well known medical device and pharmaceutical companies. It’s the best of both worlds!
About this role:
This position will be in support of new product development initiatives, specifically for US, EU, Japan, China, Brazil and Australia. You will be working on 510(k) submissions, Design Dossiers, Technical Files, Change Notices and supporting China license renewals. Authorship of US and EU submissions/documentation is required. Exposure to supporting OUS registrations is also required.
The ideal candidate will have:
- A Bachelor’s Degree and a minimum of 3 – 4 years related work experience
- Knowledge of Title 21 of the US Code of Federal Regulations (21 CFR 800-1299)
- Knowledge of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k)
- Knowledge of European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC)
- Knowledge of Risk Management Standard ISO 14971
- Knowledge of International Medical Device requirements (China, Japan, Canada, Australia, Brazil, Russia, etc.)
- Experience with establishment license maintenance and device listing in the US
- Experience with FDA systems (FURLS and CECATS)
- Knowledge of Quality Management System Standard ISO 13485 and MDSAP
- Excellent written and oral communication skills, good analytical thinking, organization and problem-solving skills
- Proficiency in Microsoft Office and all related applications