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 www.grifols.com. 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
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