Regulatory Affairs Leader

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 also develop clinical software applications and laboratory instrumentation systems enhancing patient care.

We operate directly in 30 countries, and in more than 100 territories through distributors. Our headquarters and technology centers are located in Europe and the United States, and our workforce is more than 7,000 strong.

In Werfen, our purpose is to contribute to the advancement of patient care around the world through innovative specialized diagnostics solutions. 

Job Summary

This position, Regulatory Affairs Leader, provides effective regulatory support for company’s manufactured products and customer’s products. Prepare and submit the documentation according to the corresponding legislation for the different countries.

Be responsible for the implementation of new regulatory requirements.

Key Accountabilities

• Prepare the required documentation to obtain the CE mark, FDA or other country registrations for the company’s manufactured products or customer’s products in accordance with the current legislations. Communication and maintenance of products with Spanish authorities.
• Support customers with any regulatory aspect.
• Follow-up and resolve the requirements emerged in the registration procedures.
• Maintain technical files as necessary to sustain product approval.
• Review product materials, labeling and/or specification sheets for compliance with applicable regulations and customer’s policies.
• Be part of the CFT projects as the RA representative.
• Support internal and external audits, validations, and product’s risk analysis.
• Follow management indicators/metrics for the proper performance of the department and apply, if necessary, the appropriate corrective actions.
• Support the Market Surveillance Department in the compilation of information for the Post Market Surveillance.
• Recommend and manage, if applicable, changes to company procedures/documents (quality system and compliance) to comply with current regulations, guidelines and/or standards.
• Provide support to Customer Service regarding import/export of the products.
• Ensure effective partnering and collaboration with R&D, Quality Operations, Design Quality and Operations to meet project goals, maintain compliance, and complete defined regulatory submissions.
• Ensure that all documentation is RA reviewed before it is shared externally with regulators and/or customers.
• Collaborate with other QRA groups, R&D, and Operations to ensure successful Regulatory Inspections.

Networking/Key relationships

To be determined based on department needs, to include interactions such as:

• All departments of the company.
• Werfen Companies.
• Customers.
• Regulatory agencies.
• Suppliers.

Minimum Knowledge & Experience required for the position:

Education:

• Required: Bachelor’s degree (diplomatura) in Life sciencies, Engieneering, or Physical Science.
• Degree may be substituted by relevant skills and work experience.
• Valuable: Any additional degree higher than the required.

Experience:

• Required : 3 years in a similar position.

Additional Skills / Knowledge:

• Software: Fluency in Office Tools (Excel & Word), Valuable Basic knowledge in SAP.
• Language: Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking)
• Standards: Valuable Knowledge of IVD legislation and Healthcare sector.

Skills & Capabilities:

The ideal candidate for this position will exhibiy the following skills and competencies:

• Management of decisions under pressure.
• Methodical and well-organized person.
• Teamwork
• Time management skills
• Ability to express information clearly and concisely to the staff, ensuring their understanding.
• Ability to apply a systematic approach and constant control, follow-up and verification of the results.
• Analytical thinking and problem solving.
• Ability to collaborate, participate and coordinate actively with working groups.
• Reflects values of Werfen in the quality of work and working relationship

Travel requirements:

Up to 5% of time.

Individual Contributor Core Competencies:

• Managing Work
• Emotional Intelligence Essentials
• Building Partnerships
• Decision Making
• Continuous Improvement
• Comtinuous Learning