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Senior Compliance Specialist
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Job Description
- Req#: EE6C5D5DA6
Employer Industry: Medical Device Technology
Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Supportive and collaborative workplace culture
- Paid time off, including a day off for your birthday
- Comprehensive benefits package, including medical, dental, vision, and 401K with a match
- Casual dress-code environment
- Opportunity to work in a fast-paced, innovative setting
What to Expect (Job Responsibilities):
- Maintain up-to-date knowledge of ICH GCP E6 R3, FDA, ISO 13485, EU MDR, and other international regulations
- Manage and support core Quality Management System (QMS) processes, including document control and complaint handling
- Oversee complaint investigation processes, including root cause analysis and Medical Device Reporting (MDR) evaluation
- Draft and review high-quality technical documents, including SOPs and audit reports
- Foster a culture of continuous improvement and compliance through proactive communication and collaboration
What is Required (Qualifications):
- Bachelor's degree in a life science, engineering, or related field, or equivalent combination of education and experience
- Minimum 3 years of experience in a quality assurance, regulatory, or compliance role in a medical device, digital health, or life sciences environment
- Strong knowledge of Good Clinical Practice (GCP) and international regulatory requirements
- Demonstrated experience managing CAPAs and conducting internal/external GCP audits
- Excellent technical writing and verbal communication skills
How to Stand Out (Preferred Qualifications):
- Experience with QMS tools (specifically QT9)
- Experience in a fast-paced, innovative, or scaling organization
- Familiarity with digital health technologies or wearable medical devices
- Experience with complaint handling and Medical Device Reporting
#MedicalDevice #Compliance #QualityManagement #CareerOpportunity #InnovativeWorkplace
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