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Regulatory Affairs Project Manager - Device Central NJ Perm/Full

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Regulatory Affairs Project Manager - Device
Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines. Ensure compliance to all US, EU and Spine requirements as well as to corporate policies and procedures regarding submissions and other requirements for market approval of medical devices. Apply scientific principles to understanding safety and efficacy on a wide range of products.
 
  • Participate on product development teams to insure US and EU regulatory requirements are incorporated as part of the development process
     
  • Author submissions and other regulatory documents to obtain approval to market.
     
  • Assist in post market submissions (annual reports, progress reports, etc.).
     
  • Review and approve labels, labeling and marketing/sales collateral materials for pre and post - market applications
     
  • Support marketing, R&D and Manufacturing teams in regulatory assessment of proposed changes or product transfers.
     
  • Address and advise teams on appropriate pathways to market.
     
  • Interface and coordinate with the FDA and other regulatory agencies on submissions, approvals or other issues.
     
  • Establish and maintain regulatory information systems both electronically and hard copy.
     
  • Interpret existing and/or new regulatory requirements as they relate to company products and procedures and communicate this to appropriate personnel.
     
  • Review and approve change requests while considering both United States and international regulatory requirements.
     
  • Prepare and update US product listings and EU registrations.
     
  • Communicate any regulatory body correspondence on submissions to the appropriate team(s) and RA management.
    Develop, implement and maintain regulatory standard operating procedures (SOP's).
     
  • Conduct regulatory training.
     

    Qualifications:
     

  • 510(k) preparation experience, IDE and PMA preparation experience a plus.
     
  • Preparation of EU Technical Files and Design Dossiers a plus.
     
  • Minimum 3-5 years experience in FDA regulated industry. Experience in EU regulated industry a plus.
     
  • Working knowledge of FDA Medical Device Regulations.
  • Working knowledge of EU Medical Device Regulations a plus.
     
  • Direct interaction with FDA reviewers/inspectors.
     
  • Direct interaction with Notified Bodies and Competent Authorities a plus.
     
  • Team based work environment experience preferred.
     
  • Strong interpersonal, written, oral, communication and organizational skills.
     
  • Working knowledge of personal computer systems and desktop office applications
     
  • Sound understanding of scientific principles
     

    Education:
     

  • BA/BS in Scientific discipline or BA/BS any major with equivalent work experience. RAC certification desired.
    		•