International RA Specialist (LS-220672)
Start Date: ASAP
Location: Northeast
Duration: 6+ Months
Pay Rate: DOE
Type: Contract
Job Description Our Client is looking for an International Regulatory Affairs Specialist  who will support international regulatory affairs activities, including but not limited to the following: 

  • Assisting in providing international regulatory expertise to new product development and sustaining engineering team's preparation and submission of regulatory documentation for product registration/licensing in selected global markets (AZN, Brazil, Russia and other non G9 EU countries from Asia (China and Japan).
  • Work with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assist in review of international product labeling and marketing materials
  • Assist in development of regulatory processes and work instructions/SOPs and training material for Rest of the world submissions
  • Assist in the preparation of global registration dossiers to obtain product registrations in Asia and other markets worldwide
  • Participate, as directed, in new product development teams to ensure understanding of global regulatory requirements.
  • Support team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations
  • Assist in obtaining Certificates of Export from FDA, Certificate of Analysis, Apostille, or other applicable import/export notifications as needed
  • Support maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals
  • Provide progress of work-plans and the status of key project deliverables
  • Assist with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining if regulatory submissions are required
  • Provide assistance in keeping abreast of changes and proposed changes to the worldwide regulatory requirements related to company products and processes
  • As needed, assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes
  • Support compliance activities related to global regulations and international standards; May assist in the performance of internal quality and regulatory compliance audits and the evaluation and monitoring of corrective actions.


Education:
Degree in engineering or life sciences is required; 


Requirements:
  • Strong understanding of Risk Management process, label and labeling, change management is desired
  • ISO 13485, ISO 9001, MDR, MEDDEV, QSR experience is required; reasonable understanding of US regulatory, CE mark pertaining to Technical Files and Design Dossiers is required
  • RAC accreditation (through RAPS) is a plus
  • Strong Project Management skills required and experience with SAP, Oracle PLMs, Agile,    Windchill is desirable
  • Language skills in Chinese/Mandarin and/or Japanese is a plus.
  • Must be able to communicate effectively (verbal and written)
  • Must be proficient in Microsoft Office (Word, Excel, PowerPoint)
  • Ability to work in team environment, has to be a self-starter with ability to work independently
  • Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors is essential
  • Must be able to meet deadlines and be detailed orientated
  • Good planning and organization skills are desired
  • Strong critical thinking and problem solving skills are preferred
  • Willingness to travel up to 5% of the time (domestic and international)

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