Job Description

POSITION SUMMARY:

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 include but are not limited to:

• 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

Qualifications

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.

Additional Information

Position is Full Time, Monday – Friday First Shift with overtime as business needs require.

** What we offer:**

• 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
• Yearly goal-based bonus & eligibility for merit-based increases

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