Clinical Study Manager in Irvine, CA at Apex Life Sciences

Date Posted: 10/28/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Irvine, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    10/28/2018
  • Job ID:
    881327

Job Description


Apex Life Sciences is looking for a Clinical Study Manager for a global in-vitro diagnostic manufacturer in Irvine, CA!

Responsibilities:

  • Point person with clinical sites, reviews and prepares clinical study protocol, including data management in support of 510K submissions.
  • Facilitates search and qualification of clinical sites in the US including site start-up activities and study protocol training
  • Manages information to be submitted to regulatory authorities and acts as liaison
  • Assist Regulatory & Compliance as necessary in supporting the handling of product complaints for MDR, Vigilance, Canadian Medical Device reporting requirements and preparation of Health Hazard Evaluations.
  • Oversight of company’s QMS, submitting on time, within budget, and meeting regulatory requirements
  • Interprets regulations and provides sales, marketing, and global regulatory teams with constructive regulatory guidance and recommendations.
  • Support completion of product license applications, develop content/format for regulatory submissions, such as 510(k)s and Canadian registrations for IVD products.
  • Serve as Regulatory Affairs representative in review and approval of marketing/promotional, sales training, packaging & labeling materials
  • Participates in obtaining 510(k) clearance, contributes to writing pre-submissions and 510(k) submittals, and interacts with FDA in matters related to pre-submissions, 510(k) files and follow-up meetings.


Requirements:

  • MS with 4 to 6 years of experience or BS degree with 7 to 9 years of experience
  • Experience with hematology. 
  • Familiar with product registrations (globally)

#LI-MM2

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




881327