Regulatory Affairs Associate

Eurofins • Kalamazoo, MI

21h

About The Position

POSITION SUMMARY:
We are seeking an experienced Regulatory Affairs Associate to support our Human Health and Animal Health Diagnostics Groups, specifically focused on 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 include but are not limited to:

Requirements

• Authorization to work in the United States indefinitely without restriction or sponsorship
• Minimum of BS/BA in a relevant discipline as regulatory and/or biology
• 3-5 years direct human health In Vitro Diagnostics experience and/or Animal Health Diagnostics.
• 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 with colleagues at various levels of the organization.
• Attention to detail to ensure all expectations for regulatory documents 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.

Nice To Haves

• knowledge of SAP, Veeva Vault and Trackwise.

Responsibilities

• Assist with preparing and review of regulatory documentation for medical devices (e.g. 510(k), CLIA Waivers and Technical Files).
• Ensure compliance with FDA, EU In Vitro Diagnostic Device Regulation, and other international regulatory requirements and appropriate regulatory requirements are provided to support global registrations.
• Utilize checklist, symbol standards, and regulatory guidance’s 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.
• Assess product changes for potential global regulatory impact.
• Collaborate with the cross-functional development teams to ensure regulatory project needs are met.

Benefits

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level