MAE Consulting Group

Careers

 

– Regulatory Affairs Specialist II in Deerfield, NH –

Responsible for diverse regulatory functions, including but not exclusive to the development of medical device regulatory strategies, submissions and the implementation of regulatory compliance.  Provide timely and valued regulatory support by owning the following tasks with minimal supervision:

  • Develop regulatory strategies based on client target market(s)
  • Create project plans using Microsoft Project to provide client with a detailed project tasks and timelines to set project and product expectations
  • Review all documentation provided by client in preparation of product application to ensure compliance to standards, guidance documents, etc. and ensure most accurate submission to minimize RAI and/or RTA notifications
  • Prepare regulatory submissions for global markets, submit to agencies and gain approval
  • Conduct research and interface with clinical affairs staff for clinical trials required in support of product application and approval
  • Provide assistance in product notification and recall activities
  • Maintain country-specific product registrations including license renewals, establishment registrations and device listing requirements
  • Maintain current knowledge of developments and changes to applicable laws, regulations and industry standards
  • Provide support for FDA, EU and other global inspections at client site, as requested
  • Maintain current knowledge associated with global standards, directives, guidance documents and policies applicable to MAE Group and client’s products
  • Maintain regulatory files in an organized and user-friendly system using documentation repositories such as Shared Drive and OneDrive
  • Direct and mentor regulatory affairs specialist staff to ensure proper coordination of information to meet regulatory and client requirements
Requirements:

Requires Master’s degree in Regulatory Affairs with an underlying Bachelor’s degree in a scientific or technical field and 6 months of experience with the following:

  • Global regulatory affairs, including development of regulatory and clinical strategies
  • Creation of applications and liaison with government officials and regulatory bodies to approval
  • Established expertise in project management of complex projects
  • Successful product submissions in the US, EU and/or Canada
  • Microsoft Project Software, Microsoft Office Products, database programs such as SharePoint, OneDrive
  • Quality System Regulations such as FDA 21 CFR 820 and ISO 13485
  • GxP such as Good Manufacturing Practices, Document Practices, Quality, Regulatory and Clinical Practices per international harmonized standards and regulations

Will work at unanticipated worksite locations throughout the U.S. Telecommuting required. Full-time position.

To apply for the position email resume to JanetK@maegroups.com. Refer to job code YR18.