Regulatory Associate at Werfen GmbH

Norcross, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Jul, 26

Salary

0.0

Posted On

16 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory affairs, FDA regulations, Medical device regulations, Quality system compliance, Labeling change requests, Annual reports, PMS reports, ISO 13485, ISO 14971, IVDR, Biologics regulations, Documentation management, Regulatory inspections, Risk management, Proofreading

Industry

Medical Equipment Manufacturing

Description

Introduction 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 Job Summary The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations, labeling change requests and tracking of field action alert documentation. Additionally, this position will support the preparation and submission of supplements and amendments to FDA for approval, which includes responding to deficiency letters. This role will also support other team members, as needed. Performs tasks that support quality system compliance with US FDA Quality System Management Regulation (21 CFR 820) and biologic regulations (21 CFR 600-680), Canadian Medical Devices Regulations (SOR/98.282), In- Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, ISO 13485:2016 and other applicable international medical device regulations. Responsibilities Key Accountabilities Routes labeling change requests for revisions to current products. Proofreads labeling drafts as requested. Prepares and submits Annual Reports, PMS reports, Medical Device Reports (MDRs), amendments, and other correspondences, as needed. Supports the collection of documents for foreign registrations. Provides general support to regulatory team members Recognize and elevate critical regulatory/compliance issues to RA management. Assist with preparation of documentation for regulatory and third-party inspections. Support regulatory tracking, archival, and information management activities. Networking/Key relationships Works closely with other Regulatory Affairs members, quality assurance, manufacturing, customer service, shipping, sales and marketing staff. Qualifications Minimum Knowledge & Experience required for the position: Education: Bachelor’s degree in science, engineering or related field required. Experience: Minimum of 1-3 years of experience in the US, EU, and international regulatory affairs within the medical device industry required. Skills & Capabilities: Knowledge of and experience with FDA medical device and/or biologics regulations and guid-ance, Regulation (EU) 2017/745 or 2017/746 (IVDR) and guidance, Good Clinical Practices guidance, ISO 13485:2016 Quality System standards, ISO 14971:2019 Risk Management, and other applicable US and international regulations, guidances, and standards, preferable. Ability to manage multiple task and deadlines. Works precisely according to procedures, rules and regulations, has a passion for continuous improvement and quality. Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company. Travel requirements:N/A Closing 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

Responsibilities

The Regulatory Associate supports regulatory activities including the preparation and submission of annual reports, PMS reports, and foreign registrations. They also ensure compliance with FDA, ISO, and international medical device regulations while managing labeling change requests and documentation.