Regulatory Affairs Specialist

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 7000 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. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

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

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Minimum Requirements:

Masters degree or equivalent in Regulatory Affairs or a related field. Employer will accept a Bachelors 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 Masters 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.

Resume submission instructions:

Individuals interested in applying for the position may submit a resume with Job #SK-1025 to

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

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 individuals 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 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 7000 employees around the world comprise our Werfen team.