Senior Principal Regulatory Affairs Specialist - Transfusion

Senior Principal Regulatory Affairs Specialist - Transfusion

Country

United States

Shift

1st

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.

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.

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.

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…