Regulatory Affairs Specialist

Werfen • Waukesha, WI

1h • $80,000 - $95,000 • Hybrid

About The Position

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.

This notice is being provided as a result of the filing of an application for permanent employment certification for the position of Regulatory Affairs Specialist by Immucor GTI Diagnostics, Inc. headquartered at 20925 Crossroads Circle, Waukesha, WI 53186. The employer intends to permanently employ a foreign national in the job opportunity described below.

Requirements

• Master’s degree or equivalent in Regulatory Affairs or a related field. Employer will accept a Bachelor’s degree or equivalent in Regulatory Affairs or a related field and one year of regulatory affairs experience at a medical device company in lieu of a Master’s degree.
• Reading and analyzing scientific documents, to include making recommendations for improvement in regard to any compliance actions outlined by Regulatory Authorities that the medical device manufacturer needs to follow.
• Applying domestic and international government regulations to Quality Systems and medical device compliance.
• Authoring registration applications for medical devices and medical device manufacturer facilities, ensuring complete and accurate submissions.
• Preparing technical files and documentation in support of product registration, ensuring compliance with appropriate regulations.
• Applying regulatory requirements to the specific application needs of Eastern Europe, the Middle East, Africa, Canada, and the U.S., including interpreting clauses and identifying nuances amongst various international codes.
• Interacting and negotiating (both verbally and written) with domestic and international medical regulatory bodies, including Eastern Europe, the Middle East, Africa, Canada, and the U.S.; responding to any inquiries that arise, to include time-sensitive matters and those with business impact.
• Monitoring and tracking expiration or renewal of license status as well as initiating communication to ensure renewal of licenses for continued business activity within specific locales.
• Monitoring any sanctions implemented by countries in which the company conducts business, to include Iran and Russia; identifying and developing a plan of action to address business impact.
• Participating in cross-functional teams to evaluate change control as it relates to any regulatory impacts.
• Presenting regulatory information and project communications (both written and verbally) to technical and non-technical audiences.
• Drug testing and background check required prior to hire.

Responsibilities

• Keep abreast of new and revised regulations, guidelines, points to consider, and compliance guides.
• Prepare and/or provide guidance so that all regulatory submissions for registrations or renewals and compliance matters are planned, communicated, and executed per regulatory and business requirements.
• Serve as a subject-matter expert on various regulations and coordinate regulatory issue resolution through the use of internal resources, regulatory agencies, and external consultants, as necessary.
• Perform tasks that support quality system compliance, including document review, complaints, vigilance reporting, inventory management, etc. with U.S. FDA (Food & Drug Administration) Quality System Regulation, Health Canada, the IVD (In-Vitro Diagnostic) Directive (98/79/EC), ISO (International Organization for Standardization) 13485, MDSAP (Medical Device Single Audit Program), IVDR (In-Vitro Diagnostic Regulation), ISO 14971, and other applicable international medical device regulations.
• Recognize and elevate critical regulatory/compliance issues to Regulatory Affairs management.
• Assist with the administration of regulatory and third-party inspections.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior