Clinical Safety Monitor in Pleasanton, CA at Apex Life Sciences

Date Posted: 7/12/2018

Job Snapshot

Job Description


A leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Products are used in hospitals, clinics and laboratories worldwide.

This position you will:

  • Works with Product Development teams on Risk Management activities to determine hazardous situations and severity levels using relevant clinical information.
  • Creates and maintains Clinical Evaluation Reports (CER) to meet MEDDEV Rev 4 requirements.
  • Supplies a medical judgement when needed to determine adverse event reportability.
  • Supports maintenance of technical files, MDD certifications and declarations of conformity in support of EU product registrations/CE mark.
  • Assists the Regulatory team with Field Action decisions by providing clinical information regarding health hazards.
  • Collaborates with cross functional teams on activities related to managing the safety of products.
  • Investigates product non-conformances to define possible hazardous situations and creates Health Hazard Evaluation (HHE) reports.
  • Participates in post-market clinical safety and risk management programs.
  • Provides input and review to regulatory or clinical documents as appropriate, to ensure these key safety documents are of high safety and scientific quality.
  • Stay up-to-date and follow all Quality Management System procedures related to this job, which can affect the quality of products or services provided to our customers.
  • Supports internal/external audits and regulatory inspections.
  • Participates on other special clinical projects as required.

Qualifications:

  • Required Master’s degree, preferably in life sciences or Biomedical Engineering, or BS degree with 10 years of clinical research experience.
  • Minimum of eight years’ experience in clinical affairs, preferably within the medical or health care industry.
  • Experience in clinical safety, clinical research, and vigilance.
  • Familiar with the development and manufacture of medical devices including Risk Management.
  • Proficient with literature searches and researching clinical information.  Proven ability to create Clinical Evaluation Reports.
  • Demonstrated in-depth knowledge of assessment of clinical device risks and benefits, and safety assessment of clinical devices both on the market and in development and global safety regulations.

#LI-VD1

To apply to this position please send your resume or contact:

Vickie Dagit, Recruiter

vdagit@apexlifesciences.com

919-334-0178

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 employeeservices@apexsystemsinc.com or 844-463-6178.