REGULATORY AFFAIRS LEADER

We are a worldwide leader in specialized diagnostics in Hemostasis, Acute Care Diagnostics, Autoimmunity and Transfusion and transplant. In addition, we research, develop, and manufacture customized assays and biomaterials through our OEM business line.As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostics products.In Werfen, we are, looking for a Regulatory Affairs Leader, She/he is responsible to 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 and is responsible for the implementation of new regulatory requirements.Knowledge & Experience:• Required: Bachelor’s degree (grado) in Life sciencies , engineering or physical science.• Valuable: Any additional degree higher than that required in the previous section.• Experience is required, 3 years in a similar position.• Fluency in Office Tools (Excel & Word), and valuable basic knowledge in SAP• Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking)• Valuable Knowledge of IVD legislation and Healthcare sector will be a plus.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.Skills & Capabilities:• 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.What we offer:• A meaningful project that will impact the quality of laboratory medicine worldwide• Multicultural and friendly team• Exciting opportunities for professional development.• Ongoing training• Social benefits: Canteen, nursery check, Language training...• Retirement PlanOur Purpose: We contribute to the advancement of patient care around the world through innovative specialized diagnosticsJOIN US!