Regulatory Manager responsible for developing global strategies for orthopedic implants at Acumed. Ensures compliance with regulatory applications and directs departmental projects.
About the role
- Regulatory Coordinator ensuring compliance with regulatory requirements and Good Clinical Practice in clinical research at Advarra. Manages IRB submissions and oversees studies from initiation through closure.
Responsibilities
- Analyzes and implements applicable regulatory requirements, institutional policies, and guidance documents to ensure the protection, welfare, and safety of research participants.
- Ensures adherence to Good Clinical Practice (GCP) standards across all phases of clinical research.
- Coordinates the submission and review process for study protocols, amendments, continuing reviews, and reportable events by the Institutional Review Board (IRB), from study initiation through closure.
Requirements
- Bachelor’s degree with 3+ years of relevant experience OR associate’s degree with 4+ years of experience.
- Demonstrated experience with an electronic regulatory filing system
- Current training in human subjects protection education, Good Clinical Practice, and HIPAA Privacy
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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