Description
Summary:The incumbent will work in the Global Regulatory Affairs department to establish and maintain appropriate systems to ensure Regulatory Compliance consistent with state, federal and international law. Assist customers by providing regulatory guidance and support. Incumbent will serve as a member of the Global Regulatory team. This position will have direct line reporting to the Sr. Director Regulatory Affairs,
Project will support audit efforts which includes global product registrations (Asia Pac, Latin America), outreach to distributors, cross-functional partnering with Quality, Engineering, and other departments. Preparation of U.S. 510(k) regulatory submissions, preparation/maintenance of Technical Files for European CE products. Prepare regulatory submissions for health authorities in other countries. Prepare and maintain state and federal medical device licensing, establishment registration and listings. Obtain regulatory permits, including import / export clearance requirements. Regulatory assessment of new and changed products. Labeling / marketing material review. Participate in Project Teams and New Product Introduction Teams.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience requirements:
* BS degree in relative discipline
* Must have a minimum of 5 years of Regulatory Affairs Medical Device technical work experience, or an equivalent combination of education and experience. Regulatory certification is a plus.
* Medical device regulatory affairs: Regulations, Submissions (510(k), PMA, IDE), Technical Files, cGMP/Quality Systems, Regulatory Compliance and Import/Export regulations for class I and II devices.
* Direct and positive experience in communicating with Regulatory Authorities and Distributors.
* Multi-site experience, in a mid to large size company.
To find out more about Real please visit www.realstaffing.com