Regulatory Affairs Specialist

4 hours ago


Reston, Virginia, United States Accordance Search Group Full time
Job Summary

We are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at Accordance Search Group.

This is a challenging and rewarding role that requires a strong understanding of regulatory requirements and a proven track record of success in ensuring compliance.

Key Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with FDA and international regulations
  • Prepare and submit regulatory applications, including 510(k) applications and PMA supplements
  • Coordinate and compile regulatory submissions, including European Dossiers and other country-specific product registrations
  • Represent Regulatory Affairs on cross-functional product development and manufacturing support teams
  • Maintain annual licenses, registrations, and listing information
  • Assist with compliance to product post-marketing approval requirements
  • Subject Matter Expert (SME) for audits and inspections by internal teams or external regulatory authorities
  • Reviews, edits, and approves Advertising and Promotional materials
  • Acts as liaison between the Company and in-country affiliates as well as the various regulatory agencies
  • Maintains ongoing surveillance and analysis of all pertinent medical device regulations
Requirements
  • Bachelor's Degree in a scientific discipline, e.g. Chemistry, Life Sciences, Biology
  • Minimum 5 years' experience working with Class II and/or Class III medical devices
  • Regulatory Affairs Certification (RAC) is a plus
  • Experience with 510(k) applications, PMA supplements, and US device regulations, or with EU and other international medical device regulations and submissions
  • Must be familiar with relevant regulatory requirements for medical devices, including Quality Systems standards and clinical investigations
  • Experience with word processing, spreadsheet, and presentation graphic software packages
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage and/or engage others to accomplish projects
  • Ability to identify, solve problems, and work independently with little oversight
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Multitasks, prioritizes, and meets deadlines in a timely manner
  • Strong organizational and follow-up skills, as well as attention to detail
  • Ability to travel approximately 5%, including international travel
  • Ability to maintain regular and predictable attendance


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