Associate Human Health Diagnostics Regulatory Affairs
Company Description
The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package. 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 our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. If you’re looking for a rewarding career, a place to call home, apply with us today!
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. Apply tot his job Apply To this Job