Regulatory Operations Coordinator
Location
Idaho
Posted
99 days ago
Salary
$57.9K - $85.4K / year
Bachelor Degree2 yrs expEnglish
Job Description
• Organize and support management review meetings in accordance with applicable SOPs
• Work closely with subject matter experts to ensure suppliers meet quality expectations through audits, performance monitoring, and corrective actions when necessary
• Negotiate and maintain quality agreements with suppliers and manufacturers for MWI’s premium brands
• Respond promptly to audit inspection inquiries by providing accurate information and supporting documentation
• Work with the management teams to develop follow-up action plans for addressing any identified non-compliance issues
• Review and manage the documentation on adverse events and quality complaint incidents. Provide quality input for investigations and support corrective and preventive action initiatives to address root causes
• Organize regular reviews Standard Operating Procedures (SOPs) and Work Instructions (WIs) with process owners to these documents align with established service standards as well as quality and regulatory requirements
• Verify adherence of MWI employees to all company policies and procedures as applicable to their role and responsibilities through effective monitoring, guidance, and support during standard process implementation
• Ensure that MWI License(s) as well as any other regulatory documentation is up to date
• Identify opportunities for process improvements through data analysis and continuous evaluation of existing workflows.
Job Requirements
- Bachelor's degree preferred, in healthcare or science discipline or 2 years of professional experience in a healthcare setting or pharmaceutical company.
- Working knowledge of FDA guidelines for post-marketing drug and medical device safety surveillance.
- Experience in auditing, risk management, and/or quality management.
- Knowledge of QMS software preferred.
Benefits
- Health insurance
- 401(k) matching
- Paid parental leave
- Paid caregiver leave
- Behavioral health solutions
- Adoption assistance
- Infertility coverage
- Family building support
- Backup dependent care
- Professional development resources
- Mentorship programs
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