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Regulatory Affairs Coordinator

Company: Aerotek
Location: Bridgewater
Posted on: April 9, 2021

Job Description:

Provide Information and Regulatory Support to International RA team members for Surgical Device Registrations, Renewals, Launches, etc. To provide support and needed information to all global regions on all US medical devices across the Valeant/B+L/Valeant subsidiaries so that regions can file products with the data necessary for their submissions. This role was created due to the decentralized Valeant company structure.Responsible for providing Regulatory Affairs support to International RA teams for product registrations, renewals to global markets for medical devices . The incumbent will provide support and applications for all requested documents (certificates/letters), search and retrieve product labeling & all needed support documentation.With the oversight of Regulatory leadership, the incumbent will prepare and obtain:

  • Letter of Authorizations/Letter of Declaration/Power of Attorney Letters Certificate of Free Sale from State of NJ/ CPP from Federal Agency ( FDA) Notarized, Legalized, or Apostilled Regulatory DocumentsTechnical Inquiries and coordination (including Manufacturing, process, raw materials, technical files)- Search and retrieve documents from RA system and tools and provide links to the international requestors (Sharepoint, Documentum) where information can be found. Work with other International Support groups (Operations, QA, etc.) to provide assistance to regions.Additional Skills & Qualifications:
    • BS degree in a technical or scientific discipline.
    • A minimum of 3 years of experience in device. About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Trenton , Regulatory Affairs Coordinator, Other , Bridgewater, New Jersey

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