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Clinical Quality and Compliance Manager @C20 Cochlear Americas (USA)

[Hiring] Clinical Quality and Compliance Manager @C20 Cochlear Americas (USA)

Mar 21, 2025 - C20 Cochlear Americas (USA) is hiring a remote Clinical Quality and Compliance Manager. 💸 Salary: $109,000 - $130,000 per year plus 15% bonus. 📍Location: USA.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

This role involves managing clinical quality and compliance for Cochlear's clinical research activities.

  • Enabling process owners in the development, maintenance, and deployment of clinical research quality management processes that comply with applicable CAM regional regulations, global ethical and good clinical practice (GCP) standards, and Cochlear’s quality management system (QMS).
  • Execution and support of quality control and quality assurance activities that monitor quality and compliance in the conduct of clinical research activities.
  • Facilitating the implementation of clinical systems for electronic trial master file and clinical trial management.
  • Support FDA inspections, internal Quality, and conduct Clinical Studies audits; support corrective actions needed for any findings during audits.
  • Support the implementation of new clinical research systems as needed to facilitate the development of the clinical infrastructure to enhance the efficient execution of compliant clinical research activities.

Qualifications

  • Bachelor’s in healthcare, Life Sciences, Nursing, Public Health, or equivalent.
  • Minimum of 5 years of relevant clinical research experience.
  • Working knowledge and experience in practical application of Good Clinical Practice principles.
  • Working knowledge and experience in practical application of either pharmaceutical or medical device regulations including 21 Code of Federal Regulations Part 812 or 312.
  • Experience providing subject matter contribution to the development or maintenance of quality management process development to align with GCP and applicable regulations.
  • Experience contributing or leading to relevant quality or performance activities such as metrics, auditing, CAPA root cause or effectiveness monitoring, QMS implementation or transition planning.
  • Prior experience with regulatory inspections.

Requirements

  • Must have knowledge of and experience in practical application of Good Clinical Practice principles.
  • Must have experience in either pharmaceutical or medical device regulations including 21 CFR part 812 or 312.

Benefits

  • Competitive wages and benefits.
  • Pay Range in the United States: $109,000 - $130,000 per year based upon experience, as well as an annual bonus opportunity of 15% of base salary.
  • Benefit package includes medical, dental, vision, life and disability insurance.
  • 401(K) matching with immediate vesting.
  • Paid Time Off.
  • Tuition reimbursement.
  • Maternity and paternity leave.
  • Employee Stock Purchase Plan.
  • Pet insurance.

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📍 Be aware of the location restriction for this remote position: USA
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Back to Remote jobs  >   All others
Clinical Quality and Compliance Manager @C20 Cochlear Americas (USA)
All others
Salary 💸 $109,000 - $130,000 per year plus 15% bonus
Remote Location
USA
Job Type full-time
Posted Mar 21, 2025
Apply for this position Unlock 53,639 Remote Jobs
📍 Be aware of the location restriction for this remote position: USA
Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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