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Regulatory Affairs Specialist Clinical Diagnostic
hace 2 meses
About Grifols
Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. 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.
Our Commitment to Diversity and Inclusion
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.
About the Job
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.
Key Responsibilities- Regulatory Compliance Management
You will carry out activities that ensure compliance with regulatory requirements throughout the life cycle of products, from development to marketing.
Documentation ReviewYou will review documentation related to product design taking into account applicable regulations.
Regulatory ClassificationYou will determine the Regulatory Classification of the products and the applicable standards.
Regulatory Dossier CreationYou will create regulatory dossiers worldwide and verify compliance with regulatory requirements.
Labeling ReviewYou will perform the review of labeling in accordance with current regulations.
Report ConsistencyYou will supervise the consistency of the reports that support the registration of products in accordance with current standards (e.g. Technical Files CE, 510k, BLA, PMA, annual reports).
Technical DocumentationYou will draft letters and Technical Documentation that should be submitted to Regulatory Authorities or other Certifying Bodies.
Response to Deficiency LettersYou will participate in the preparation of responses to deficiency letters sent by Regulatory Authorities/ Notified Bodies.
Regulatory Impact AssessmentYou will determine the Regulatory Impact of changes in Products, Manufacturing Processes and Facilities.
Regulatory UpdatesYou will keep up to date of the standards and regulations applicable to the Diagnostic Business Unit products.
Technical BulletinsYou will draft Technical Bulletins related to labeling changes that should be shared with the customers.
AuditsYou will be involved in internal and external audits as needed.
RequirementsTo 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.
Education
You have a Bachelor's degree in Health Sciences (Biomedicine, Biotechnology, Biology, Biochemistry or related).
Experience
You have minimum 2 to 3 years of experience working in Regulatory Affairs.
