Regulatory Operations Coordinator
1 week ago
We are seeking a highly skilled Regulatory Coordinator to join our team in the medical device industry.
Key Responsibilities:- Work with PMS Analysts to develop and maintain Post Market Surveillance plans and reports, ensuring compliance with regulatory requirements.
- Attend cross-functional meetings and track open items to ensure timely issue resolution.
- Collaborate with product teams to establish and maintain Product Requirements (PMS Plans, Reports, Periodic Safety Update Reports).
- Bachelor's degree with 1-2 years of experience in a regulated field environment, preferably in medical devices.
- Proficiency in Microsoft Office applications, including Word, Excel, Access, PowerPoint, Project, and Outlook.
- Experience working with local and long-distance project teams to drive initiatives or processes in a global organization.
- Familiarity with GMPs and Medical Device Directive regulations.
- $18-$20 per hour on W-2.
- 6-month contract role.
- Medical, dental, vision, and 401(k) benefits.
- Weekly pay with direct deposit.
- Consultant Care support.
- Dedicated Career Partner for career development.
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