Regulatory Affairs Lead

Werfen; Cataluña; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Werfen, founded in 1966 and headquartered in Barcelona, Spain, is a world leader in diagnostics. This Regulatory Affairs position provides effective support for regulatory submissions and compliance for our products and customers.

The role involves preparing CE and FDA documentation, liaising with Spanish authorities, maintaining files, and collaborating with R&D and Quality teams to ensure successful regulatory submissions and inspections. Fluency in English and Spanish or Catalan is required.

Formación

• Bachelor’s degree in Life Sciences, Engineering, or Physical Science.
• Any additional degree higher than required is a plus.
• 3 years of experience in a similar position.

Responsabilidades

• Prepare documentation to obtain CE mark, FDA, or other country registrations.
• Communicate with Spanish authorities and maintain regulatory files.
• Support customers with regulatory aspects and follow up on requirements.
• Maintain technical files and ensure compliance of materials and labeling.
• Serve as RA representative in cross-functional projects and assist audits.
• Collaborate with R&D, Quality Operations, and Design Quality to meet submissions.

Conocimientos

Decision making under pressure

Organizational skills

Teamwork

Clear communication

Analytical thinking

Problem solving

Collaboration

Educación

Bachelor’s degree in Life Sciences, Engineering, or Physical Science

Additional degree valued

Herramientas

Excel

Word

SAP

Descripción del empleo

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.

Overview

This position 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.

Responsibilities

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 current legislation. Communication and maintenance of products with Spanish authorities.

Support customers with any regulatory aspect.

Follow up and resolve requirements that emerge during 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 policies.

Be part of CFT projects as the RA representative.

Support internal and external audits, validations, and product risk analysis.

Follow management indicators/metrics for the proper performance of the department and apply appropriate corrective actions if necessary.

Support the Market Surveillance Department in compiling information for 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 product import/export.

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 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.

Internal Networking

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

All departments of the company.

Customers.

Regulatory agencies.

Qualifications

Minimum Knowledge & Experience required for the position

Required: Bachelor’s degree (diplomatura) in Life Sciences, Engineering, or Physical Science.

Valuable: Any additional degree higher than required.

• Years of experience

  • Required: 3 years in a similar position.

• Min knowledge

  • Software: Fluency in Office Tools (Excel & Word); basic knowledge of SAP is valuable.

  • Languages: Fluency in Spanish or Catalan; advanced knowledge of English (reading and speaking).

  • Standards: Knowledge of IVD legislation and the healthcare sector is valuable.

Skills & Capabilities

Management of decisions under pressure.

Methodical and well-organized approach.

Teamwork.

Ability to express information clearly and concisely to staff, ensuring understanding.

Ability to apply a systematic approach with constant control, follow-up, and verification of results.

Analytical thinking and problem-solving.

Ability to collaborate, participate, and coordinate actively with working groups.

Reflects Werfen values in work quality and working relationships.

Travel Requirements

Up to 5% of time.

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.