Regulatory Affairs Specialist

Regulatory Affairs Specialist

Job Locations

US-GA-Norcross

Job ID

2024-3546

Category

Regulatory Affairs

Overview

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.

We are seeking a Regulatory Affairs Specialist to join our Regulatory Affairs team. As a Regulatory Affairs Specialist, you will have an opportunity to have visibility amongst your peers to perform a variety of regulatory affairs tasks in a vibrant work environment. If you've got the necessary skills and experience to excel in this positiion, we want to hear from you. Apply today!

This position is not eligible for sponsorship for work authorization. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

Regulatory Affairs Specialist/Quality Assurance/ IVD

Responsibilities

Key Accountabilities

Reviews and approves quality system documents to determine compliance with SOPs, quality system and regulatory compliance, and industry standards
• Maintain regulatory product files of information submitted in support of domestic and international registrations
• Coordinates field action and vigilance activities for Werfen product lines and notifies appropriate regulatory agencies, affiliates and distributors
• Performs tasks and functions associated with product recalls/field corrections including preparing customer notifications, government submissions, status reports and recall effectiveness checks
• Maintains compliance with Medical Device Listing requirements for Werfen products
• Prepares and maintains Technical Files (Technical Documentation)
• Reviews and approves significant changes (e.g. facility, product, process and labeling changes) for regulatory impact and domestic and international reporting requirements
• Recognizes and elevates critical regulatory/compliance issues to RA management
• Performs other duties as assigned

Regulatory Affairs Specialist/Quality Assurance/ IVD

Qualifications

Minimum Knowledge & Experience required for the position:

• Bachelor's degree (BS/BA) from four-year college or university; or equivalent combination of education and experience
• Minimum 2 years experience in a quality assurance and/or regulatory affairs position, preferred
• RAC certification, preferred (Regulatory Affairs Certification), preferred
• Knowledge of Quality System Requirements and general regulatory affairs' regulations
• Experience writing, reviewing and editing technical documents
• MS-Office Applications

Regulatory Affairs Specialist/Quality Assurance/ IVD

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com

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