Job Description

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:

• 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.

Qualifications

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.
• 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 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.

Additional Information

• Position is full-time, Monday to Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Kalamazoo, MI are encouraged to apply.

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

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.