Regulatory Operations Coordinator

ComplianceComplianceFull TimeRemoteTeam 11-50H1B No SponsorCompany SiteLinkedIn

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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