Senior Principal Regulatory Affairs Specialist - Transfusion

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

The Sr. Principal Regulatory Affairs Specialist represents Regulatory Affairs on product lifecycle teams by actively contributing to the development and implementation of regulatory strategies. Independently prepares and negotiates regulatory submissions for new products and product changes as required to ensure timely approval for market release. Performs tasks that support quality system compliance with US FDA Quality System Management Regulation (21 CFR 820) and biologic regulations (21 CFR 600-680), Canadian Medical Devices Regulations (SOR/98.282), In- Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, ISO 13485:2016 and other applicable international medical device regulations.

Key Accountabilities

• Prepares and submits product applications: 510(k), BLA, PMA or their equivalent in foreign markets. Responds to deficiencies and/or questions related to regulatory submissions.
• Represents Regulatory Affairs on product lifecycle teams and on Product Development Process (PDP) projects.
• Review and approve quality system documents to determine compliance with regulatory regulations and standards.
• Review change orders for regulatory impact and domestic and international reporting requirements. Develop regulatory strategies for implementation.
• Evaluate complaint, deviation and OOS data to determine the need for medical event reporting, field action or biological product deviation reporting.
• Write and maintain departmental SOPs.
• Create and maintain Technical Files.
• Recognize and elevate critical regulatory/compliance issues to RA management.
• Assist with the administration of regulatory and third-part inspections.
• Provide training and support/mentoring to new/junior members of the department.
• Track quality metrics for RA department.
• Support/Lead complex regulatory submissions.
• Acquire and maintain current knowledge of applicable regulatory requirments and scientific/technical issues in the geographic and discipline as relevant to assigned projects.

Networking/Key Relationships

Works closely with other Regulatory Affairs members, quality, quality assurance, manufacturing, 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 and regulations, has a passion for continuous improvement and quality.
• Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.

Travel Requirements:

Approximate percentage of travelling time: 10%.

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