Senior Principal Regulatory Affairs Specialist - Transfusion

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 As a Senior Principal Regulatory Affairs Specialist, you will perform regulatory affairs and quality system support activities associated with the manufacture and distribution of the Werfen product lines for U.S., Canada, and European Union. Responsibilities Key Accountabilities Coordinates preparation, review and submission of product applications (510(k), BLA, Medical Device Licence Applications/Amendments, and Technical Documentation Prepares and maintains Technical Files (Technical Documentation) Reviews and approves quality system documents to determine compliance with SOPs, quality system and regulatory compliance, and industry standards Reviews and approves significant changes (e.g. facility, product, process and labeling changes) for regulatory impact and domestic and international reporting requirements 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 Evaluates complaint and internal deviation report data to determine the need for Medical Device Reporting, field action or Biological Product Deviation reporting Maintains compliance with Medical Device Listing requirements for Werfen products Recognizes and elevates critical regulatory/compliance issues to RA management Assists with the administration of regulatory and third-party inspections. Performs other duties as assigned Networking/Key Relationships Works closely with other R & D staff members, quality control, quality assurance, 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. RAPS certification and membership, preferred Experience: Minimum of eight (8) years of experience in the US, EU, and international regulatory affairs within the medical device industry required. Thorough knowledge of the product development and design control process. Skills & Capabilities: Sophisticated knowledge of and experience with FDA medical device and/or biologics regula-tions and guidance, Regulation (EU) 2017/745 or 2017/746 (IVDR) and guidance, Good Clinical Practices guidance, ISO 1348:2016 Quality System standards, ISO 14971:2019 Risk Manage-ment, and other applicable US and international regulations, guidances, and standards required. 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: 10% Closing 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 View email address on click.appcast.io 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. #J-18808-Ljbffr Werfen