Regulatory Affairs Specialist Clinical Diagnostic

Grifols; Derio; Presencial; EUR 35.000 - 55.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Regulatory Affairs Specialist to join their team. This role involves ensuring global regulatory compliance for innovative healthcare products. You will manage regulatory dossiers, oversee product safety, and collaborate with cross-functional teams. The company values diversity and is committed to fostering an inclusive environment. This is a fantastic opportunity to contribute to the healthcare sector and enhance the lives of millions. If you have a background in health sciences and experience in regulatory affairs, this role could be your next career step.

Formación

• 2-3 years of experience in Regulatory Affairs required.
• Experience in developing immunoassays or molecular biology products preferred.

Responsabilidades

• Ensure compliance with regulatory requirements throughout product life cycle.
• Create and review regulatory dossiers and technical documentation.
• Participate in internal and external audits as needed.

Conocimientos

Regulatory Affairs

Communication Skills

Organizational Skills

Knowledge of GMP

Team Collaboration

Educación

Bachelor's in Health Sciences

Descripción del empleo

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.

At Progenika Biopharma ., a Grifols company, we are looking for a Regulatory Affairs Specialist to ensure global regulatory compliance by managing regulatory dossiers, technical documentation, product renewal and changes, and communication with authorities, to ensure product safety and effectiveness.

What your responsibilities will be

• You will carry out activities that ensure compliance with regulatory requirements throughout the life cycle of products, from development to marketing.
• You will review documentation related to product design taking into account applicable regulations.
• You will determine the Regulatory Classification of the products and the applicable standards.
• You will create regulatory dossiers worldwide and verify compliance with regulatory requirements.
• You will perform the review of labeling in accordance with current regulations.
• You will supervise the consistency of the reports that support the registration of products in accordance with current standards (. Technical Files CE, 510k, BLA, PMA, annual reports, etc)
• You will draft letters and Technical Documentation that should be submitted to Regulatory Authorities or other Certifying Bodies.
• You will participate in the preparation of responses to deficiency letters sent by Regulatory Authorities / Notified Bodies.
• You will determine the Regulatory Impact of changes in Products, Manufacturing Processes and Facilities.
• You will keep up to date of the standards and regulations applicable to the Diagnostic Business Unit products.
• You will draft Technical Bulletins related to labeling changes that should be shared with the customers.
• You will be involved in internal and external audits as needed.

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).

• You have a Bachelor’s degree in Health Sciences (Biomedicine, Biotechnology, Biology, Biochemistry or related).
• You have minimum 2 to 3 years of experience working in Regulatory Affairs.
• You have experience or have participated in the development of the immunoassays and / or molecular biology products (IVD / MD products)
• You possess an advanced level of English (C1.1).
• Knowledge and application of work standards (GMP, SOP, INS, GLP, ISO 13485, according to defined procedures.
• You have excellent communications skills and the ability to work in cross-functional teams.
• You are an organized, proactive and dynamic person with the capacity for continuous learning.

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!