Regulatory Affairs Specialist Lab Automation
hace 4 días
Regulatory Affairs Specialist Lab Automation Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment. What your responsibilities will be Act as an interface with Regulatory Authorities/Notified Bodies. Determine the Regulatory Classification of the products and the applicable standards. Create regulatory dossiers and verify compliance with regulatory requirements. Coordinate the reviews of labeling in accordance with current regulations. Supervise the consistency of the reports that support the registration of products in accordance with current standards (e.g., Technical Files CE, 510(k), BLA, annual reports, etc). Draft letters and Technical Documentation that should be submitted to Regulatory Authorities or other Certifying Bodies. Determine the Regulatory Impact of changes in Products, Manufacturing Processes and Facilities. Be up to date with the standards and regulations applicable to the Diagnostic Business Unit products. Draft Technical Documentation related to labeling changes that should be shared with the customers. Who you are To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Bachelor’s Degree in Pharmacy, Chemistry, Biology, Biomedical Engineering, or a related Life Sciences/Scientific field. Between 2-5 years of experience in technical and regulatory documentation. Prior experience with IVDR and FDA regulations within the Medical Device or IVD industry is highly valued. Ability to act as a primary point of contact and lead submissions with international health authorities and Notified Bodies. Methodical and detail oriented, with a rigorous approach to ensuring regulatory compliance and technical accuracy. Ability to work closely with cross‑functional teams. Advanced level of English. What we offer It is a brilliant opportunity for you. Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. Information about Grifols is available at If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply We look forward to receiving your application Grifols is an equal opportunity employer. Flexibility for U Program: Hybrid Model Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time). Benefits package Contract of Employment: Permanent position SAP / Grifols SAP as service provider: Grifols: #J-18808-Ljbffr
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Sant Cugat, España Grifols, S.A A tiempo completoA global healthcare company in Sant Cugat del Vallès seeks a Regulatory Affairs Specialist Lab Automation to enhance regulatory compliance. This hybrid position requires a Bachelor's degree in a Life Sciences field and 2-5 years of regulatory experience, specifically with IVDR and FDA regulations. The role involves maintaining interfaces with regulatory...
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Regulatory Affairs Specialist Lab Automation
hace 3 días
Sant Cugat del Vallès, España Grifols, S.A A tiempo completoRegulatory Affairs Specialist Lab Automation Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in...
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sant cugat del vallès, España Grifols A tiempo completoA global healthcare company is looking for a Regulatory Affairs Specialist in Sant Cugat del Vallès. The role includes managing regulatory submissions, ensuring compliance with international regulations, and working in a hybrid model. Candidates should have a Bachelor's degree in a relevant field and 2-5 years of experience in regulatory documentation....
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Sant Cugat del Vallès, España Grifols A tiempo completoA global healthcare company is looking for a Regulatory Affairs Specialist in Sant Cugat del Vallès. The role includes managing regulatory submissions, ensuring compliance with international regulations, and working in a hybrid model. Candidates should have a Bachelor's degree in a relevant field and 2-5 years of experience in regulatory documentation....
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Regulatory Affairs Specialist Lab Automation
hace 3 días
Sant Cugat, España Grifols, S.A A tiempo completoRegulatory Affairs Specialist Lab AutomationWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived...
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NAT Regulatory Affairs Specialist
hace 1 día
Sant Cugat del Vallès, España Grifols, S.A A tiempo completoA global healthcare company is seeking a Nucleic Acid Testing (NAT) Regulatory Affairs Specialist to join their Diagnostic Regulatory Affairs department. The candidate will prepare technical documentation, manage product registrations, and ensure compliance with regulations. Applicants should possess a Bachelor's in Health Sciences, experience in Regulatory...
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NAT Regulatory Affairs Specialist
hace 2 semanas
Sant Cugat, España Grifols, S.A A tiempo completoA global healthcare company is seeking a Nucleic Acid Testing (NAT) Regulatory Affairs Specialist to join their Diagnostic Regulatory Affairs department. The candidate will prepare technical documentation, manage product registrations, and ensure compliance with regulations. Applicants should possess a Bachelor's in Health Sciences, experience in Regulatory...
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Regulatory Affairs Specialist Lab Automation
hace 6 días
Sant Cugat del Vallès, España Grifols A tiempo completoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
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Regulatory Affairs Specialist Lab Automation
hace 3 días
sant cugat del vallès, España Grifols A tiempo completoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and...
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Regulatory Affairs Specialist
hace 4 días
sant cugat del vallès, España Grifols, S.A A tiempo completoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
