Careers

     

Senior Regulatory Affairs Specialist

 

Position overview:

The Senior Regulatory Affairs Specialist is responsible for activities which support domestic and international regulatory registrations, submissions, and reporting activities, including data and information analysis. Additionally, the Senior Regulatory Affairs Specialist will take lead roles in perfoming these and tasks in support of ongoing compliance and corporate initiatives as required.

 

JOB / DUTIES / RESPONSIBILITIES

  • Establish internal systems for regulatory approval of medical devices in international market. Compile and submit documentation as required in support of marketing initiatives.
  • Planning, organize and interpret regulatory documents for submission to various regulatory agencies.
  • Support data analysis and interpretation of clinical information.
  • Communicate submission and/or advertising and promotion requirements to internal customers such as product development teams.
  • Review product design and / or process changes for affect on regulatory submissions.
  • Recommend changes for labeling, manufacturing, and marketing for regulatory compliance.
  • Review customer contacts and assess for Medical Device and Vigilance reporting requirements. Initiate MDR and Vigilance reports as, required.
  • Other relevant duties as assigned.

JOB QUALIFICATIONS

Knowledge / Education

  • B.S. / B.A. or equivalent combination of education and experience.

  • RAPS Certification (RAC) is preferred.

Job Experience

  • Minimum 4 years of medical device industry experience.
  • Experience in dealing directly with FDA and foreign regulatory bodies is highly desired.
  • Must have analytical skills, be detail oriented and have good interpersonal skills.
  • Knowledge of federal guidelines and international requirements required.

Skills / Competencies

  • Effective verbal and written communication skills
  • Ability to communicate at multiple levels of an organization
  • PC skill, word processing, spreadsheet, database
  • Ability to organize and judge priorities
  • Ability to generate and maintain accurate records

Qualified applicants should apply online at: https://home.eease.adp.com/recruit/?id=516192