Regulatory Affairs Associate

Eurofins • Kalamazoo, MI

2d • Onsite

About The Position

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.

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
• 1-3+ 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: Entry Level