This site uses cookies. To find out more, see our Cookies Policy

Regulatory And Clinical Affairs Specialist in Irvine, CA at Apex Life Sciences

Date Posted: 12/4/2018

Job Snapshot

Job Description


Medical device company in Irvine is seeking a Regulatory and Clinical Affairs Specialist to join their team! Please send resumes to spark@apexlifesciences.com

Duties:

  • Prepare worldwide submissions for new products and product changes
  • Prepare regulatory strategies/plans and worldwide requirements lists
  • Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling, promotional materials, changes to existing devices and documentation.
  • Prepare submissions and reports for regulatory agencies as required.
  • Negotiate directly with the FDA or other international agencies, as needed.
  • Review training, promotional and advertising pieces for assigned product lines.
  • Development and implementation of regulatory and clinical strategies
  • Recruitment and management of contracted clinical support such as consultants, CRO’s, data management
  • Oversight of clinical investigator and site selection
  • Coordination and tracking of all IRB submissions and correspondence
  • Development and maintenance of study trial master files (TMF)
  • Preparation of regulatory submissions, (510(k)s, IDE’s, related FDA Correspondence), including the review of content, assembly and sign-off approval of final documents

Qualifications:

  • BS/MS required
  • 5 years Clinical, Quality or Regulatory compliance experience
  • Strong knowledge of 




916841