Associate Human Health Diagnostics Regulatory Affairs
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Job Location:
Kalamazoo, MI - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
POSITION SUMMARY:
We are seeking an experienced Regulatory Affairs Contractor 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.
Full time contractor position based in Kalamazoo MI or remote.
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
- As applicable utilize Zoetis 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.
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
