Regulatory Affairs

Werfen Immunoassay; Lliçà d'Amunt; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Werfen Immunoassay seeks an Regulatory Affairs Lead to provide regulatory support for our products and our customers. You will prepare and submit documentation according to country legislation and implement new regulatory requirements.

Responsibilities include CE/FDA registrations, maintaining technical files, reviewing materials for compliance, supporting audits, and collaborating with R&D, Quality Operations, and other teams to ensure successful regulatory submissions.

Formación

• Degree in Life Sciences, Engineering, or Physical Science required or substituted by relevant skills and experience.
• 3 years in a similar regulatory role required.
• Knowledge of IVD legislation or healthcare sector is valuable.

Responsabilidades

• Prepare documentation to obtain CE, FDA, or other country registrations for products.
• Maintain technical files to sustain product approvals.
• Review labeling and specifications for regulatory compliance.
• Support audits, validations, and risk analyses.
• Collaborate with R&D, Quality Ops, Design Quality, and Operations on submissions.
• Ensure all documents are RA-reviewed before external sharing.

Conocimientos

Decisions under pressure

Methodical

Teamwork

Clear communication

Regulatory thinking

Attention to detail

Educación

Bachelor's degree in Life Sciences/Engineering/Physical Science

Herramientas

SAP

Microsoft Office

Descripción del empleo

Please note that while the internal job title for this position is 'Regulatory Affairs Lead', this is an individual contributor role that does not involve team management or project leadership

Job Summary

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.

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.

Networking / Key Relationships

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

• All departments of the company.
• Customers.
• Regulatory agencies.

Minimum Knowledge & Experience Required

Education:

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

Experience:

• Required: 3 years in a similar position.

Additional Skills / 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.