Regulatory Affairs Specialist III
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![]() United States, Massachusetts, Bedford | |
![]() 180 Hartwell Road (Show on map) | |
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Job Information
Number
ICIMS-2025-8494
Job function
QA&RA
Job type
Full-time
Location
Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States
Country
United States
Shift
1st
About the Position Introduction
Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview
Position Summary: This position is responsible to ensure post-market regulatory activities are in compliance with domestic and international regulations. Working independently, with guidance from manager or more senior staff, the position will participate in team meetings, prepare submission and registration documentation, assess and document device changes, prepare field notifications and vigilance reports, and prepare post-market documentation. This is a technically focused role, requiring advanced skills in analyzing information, reviewing test protocols and reports, preparing regulatory documentation, and promoting regulatory compliance. Responsibilities
Key Accountabilities Essential Functions:
Secondary Functions:
Budget Managed (if applicable)
Internal Networking/Key Relationships To be determined based on department needs, to include interactions such as:
Skills & Capabilities: The ideal candidate for this position will exhibit the following skills and capabilities:
Competencies:
Qualifications
Minimum Knowledge & Experience Required for the Position: Education:
Experience:
Additional Skills/Knowledge:
International Mobility:
Travel Requirements:
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com Apply Now
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