Regulatory Operations Coordinator

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Yesterday

🥔 Idaho – Remote

Although this job is listed in Idaho, this company may be open to hiring remote in other states.

💵 $57.9k - $85.4k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

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Recruiting.com

WebsiteLinkedInAll Job Openings

Recruitment • SaaS • B2B

Recruiting. com is a recruitment platform that collects personal and non-personal information from job seekers to be used by recruiters and hiring managers. Users can submit their resumes or fill out a short form to be considered for current and future job opportunities. The site emphasizes user privacy and allows users to manage their personal data, including modifying, changing, and deleting their information. Recruiting. com securely stores user data until they request deletion, providing a comprehensive recruitment solution for both job seekers and employers.

11 - 50 employees

🎯 Recruiter

☁️ SaaS

🤝 B2B

💰 Private Equity Round on 2006-06

📋 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.

🎯 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