Regulatory Affairs Associate
Share
Job Location:
Kalamazoo, MI - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
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 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.
- Assess product changes for potential global regulatory impact.
- Collaborate with the cross-functional development teams to ensure regulatory project needs are met.
Qualifications :
Requirements:
- 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.
- 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.
Remote Work :
No
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
