Regulatory Affairs Specialist I

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:

Responsible for worldwide registration/renewal and compliance activities for Werfen-labeled products. Related duties include participation on design and risk management teams, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review, recall related activities, vigilance reporting and other regulatory work required to maintain worldwide compliance.

Responsibilities Key Accountabilities Essential Functions:

Responsible to create correction and removal files, including to author field communications with appropriate management review prior to submission, to author regulatory strategies for RA Director review and signature, to interface with Werfen departments on documentation necessary to support release and to update regulatory agencies on status through closure of field actions. Maintains records in compliance with regulations. Responsible to author FDA MDRs and Health Canada MPRs, reviewing contents with appropriate groups prior to submission. Support WW Vigilance Reporting through international European Regulatory offices. Maintains records in compliance with regulations. Responsible to participate on design and risk management teams (both Hemostasis and Critical Care) as the Regulatory representative and provide guidance on domestic and international requirements, including: Assist with new product registration packages and technical files (e.g. CE Mark, 510ks, Canadian licenses). Provide support materials for Milan Regulatory for other country registrations. Assist with product renewal packages to maintain country registrations. Responsible for preparing and maintaining Technical Files to ensure compliance. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Identify and screen historical data or reports that could be incorporated into future regulatory submissions to assure compliance with current scientific and regulatory standards. Responsible for maintenance of Regulatory Database in SAP. Responsible to review marketing promotional materials for signature by management. Responsible to review labeling and Change Orders for signature by management. Other assignments related to RA/QA to support Werfen requirements and priorities. Budget Managed (if applicable):

N/A Internal Networking/Key Relationships:

To be determined based on department needs

Skills & Capabilities:

Requires superior communication skills (verbal and written) Qualifications Minimum Knowledge & Experience Required for the

Position:

Requires a Bachelor degree, preferably in life sciences or engineering. Familiarity with ISO 13485 and 14971 preferred. Experience in the Medical Device Industry or other highly regulated environment. Proficiency with standard software (Word, Excel, PowerPoint, Adobe Acrobat etc.) Experience with SAP is a plus.

International Mobility:

Required:

No Travel Requirements: