Regulatory Affairs Specialist

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

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.

Responsibilities

Regulatory Affairs Specialist.

• 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.
• Employer offers optional hybrid work from home within commuting distance to the office

#LI-DNI

Qualifications

Minimum 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.

Work experience to include:

1. 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.
2. Applying domestic and international government regulations to Quality Systems and medical device compliance.
3. Authoring registration applications for medical devices and medical device manufacturer facilities, ensuring complete and accurate submissions.
4. Preparing technical files and documentation in support of product registration, ensuring compliance with appropriate regulations.
5. 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.
6. 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.
7. 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.
8. 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.
9. Participating in cross-functional teams to evaluate change control as it relates to any regulatory impacts.
10. 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.

40 hrs./wk. Salary: $80,000.00 to $95,000.00 per year.

Address of employment: 20925 Crossroads Circle, Waukesha, WI 53186.

Any person may provide documentary evidence bearing on the application to the Certifying Officer of the U.S. Department of Labor at the following location:

U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue NW, Room N-5311
Washington, DC 20210

EMPLOYER ATTESTATIONS:

• The Notice of Filing will be posted between 30 and 180 days before filing the permanent labor certification application.
• There is no bargaining representative for the job opportunity with the employer in the location(s) of intended employment.
• This notice was clearly visible and unobstructed while posted. It was posted for at least ten (10) consecutive business days in a conspicuous location in the workplace, where the employer’s U.S. workers could readily read the posted notice, including but not limited to locations in the immediate vicinity of the wage and hour notices.

Individuals interested in applying for the position may submit a resume with Job #SK-1025 to recruitertt@werfen.com.

Immucor GTI Diagnostics, Inc. is an Equal Opportunity/Affirmative Action Employer; Minorities/Females/Disabilities/VETs; Drug Free Workplace.

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