Adecco Engineering and Technical, a division of the world leader in the recruitment of engineering and information technology professionals, has an immediate opening for a Regulatory Submissions Specialist on a contract to hire opportunity with a leading company in Plainsboro, NJ.
Qualified candidates should possess Medical Device or Pharmaceutical industry experience and the ability to work under pressure along with experience publishing/editing/shipping/filing regulatory submissions.
The candidate would be responsible for coordination, publishing, submission and archiving of regulatory submissions in both paper and electronic format, maintaining appropriate electronic and hard copy filing systems for all regulatory communications, related documentation and back-up materials. He or she would also serve as the administrator for the electronic document management system for all regulatory documentation along with working closely with Regulatory Management to provide submission management oversight for all regulatory submissions.
Education: Bachelor Degree in Science or Business related field
Experience: A Minimum of 3-5 years working in a regulated industry is required; experience in managing regulatory submissions for device and/or drag, and biologic products.
Must have proven ability to prepare and submit documents to FDA, such as 510(k) Premarket Notifications, Investigational New Drug (IND), or New Drug Applications (NDA).
Must possess and demonstrate an excellent understanding of FDA and international regulatory requirements.
The preferred candidate must have strong writing, project management and communication skills.
If you are interested in this opportunity or other opportunities available through Adecco Engineering and Technical, please apply online.
The Adecco Group is a Fortune Global 500 company and the global leader in HR services. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your professional career. Contact us today to discuss available contract and direct hire positions. Adecco Engineering and Technical offers benefits including Holiday, 401(k), Insurance Benefit Plans and Anniversary Bonus opportunities. Adecco Engineering and Technical is an Equal Opportunity Employer.