Full-Time Associate Human Health Diagnostics Regulatory Affairs
Eurofins is hiring a remote Full-Time Associate Human Health Diagnostics Regulatory Affairs. The career level for this job opening is Experienced and is accepting Kalamazoo, MI based applicants remotely. Read complete job description before applying.
Eurofins
Job Title
Associate Human Health Diagnostics Regulatory Affairs
Posted
Career Level
Full-Time
Career Level
Experienced
Locations Accepted
Kalamazoo, MI
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Job Details
We are seeking an experienced Regulatory Affairs Associate to support our Human Health Division, specifically focused on medical device regulatory submissions and compliance. This role is ideal for a detail-oriented professional with a strong understanding and experience of global regulatory requirements and a passion for ensuring patient safety.
Job Duties:
- Prepare, review and submit regulatory documentation for medical devices (e.g. 510(k), CLIA Waivers and Technical Files)
- Ensure compliance with FDA, EU IVDR, and other international regulatory requirements
- Utilize checklist, symbol standards, and regulatory guidances to ensure label compliance with FDA and global regulatory expectations
- Collaborate with business partners to assure timely review, approval and processing of regulatory documents
- Utilize systems for entry and tracking of regulatory activities
- Manage and communicate accurate timelines for deliverables
- Regulatory Assess product changes for global regulatory impact
Requirements:
- Minimum of BS/BA in relevant discipline
- 3-5 years direct human health IVD experience and/or minimum 8 years of direct non-IVD human health regulatory experience
- Direct experience with 510(k)/CLIA waiver application experience
- Preferred: knowledge of SAP, Veeva Vault and Trackwise
- Strong verbal and written communication and organizational skills.
- High level of competency using Microsoft Office suite, Microsoft Word and Excel and Adobe Acrobat.
- Able to effectively communicate in English with colleagues at all in various levels of the organization.
- Attention to detail to ensure all expectations for labels are met.
- Flexibility and capacity to handle multiple tasks at once.
- Demonstration of a highly effective and deeply committed team player.
- Consistently models behaviors of accountability, approachability, and ownership.
- Ability to work independently, while fostering good working relationships across physical distance.
- Capable of supporting colleagues / teams in a multicultural, dynamic and constantly changing learning environment.
- Passionate and Enthusiastic
- Demonstrates “can do” energy and follow through.
Skills
FAQs
What is the last date for applying to the job?
The deadline to apply for Full-Time Associate Human Health Diagnostics Regulatory Affairs at Eurofins is
13th of December 2025
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
Kalamazoo, MI
] applicants. .
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