Diagnostic Regulatory Affairs Specialist

Job description

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.

Help us lead one of the world’s largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That’s why we need a Diagnostic Regulatory Affairs Specialist IH like you.

 

Mission

Prepare, review, and manage submissions and follow up of product registrations or any other regulatory activity, ensuring timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.             

Maintain tracking of product registrations.

 

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 labelling in accordance with current regulations.
·  Supervise the consistency of the reports that support the registration of products in accordance with current standards (Technical Files CE, 510k, 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.
·  Keep up to date with the standards and regulations applicable to the Diagnostic Business Unit products.
·  Draft Technical Documentation related to labelling 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 relevant discipline: Experimental and Health Sciences.
·  Fluent written and spoken English (C1 Advanced) and Spanish.
·  You have a Master’s degree in pharmaceutical industry and 1-2 years experience as a Regulatory Affairs specialist.
·  Ability to work under tight timelines to meet deadlines and business objectives.
·  Knowledge and application of labour standards (GMP, PNT, INS, GLP, etc...) according to procedures definite.
·  Monitoring of quality, safety, hygiene, and environmental standards.
·  Computer skills (such as MS Office, databases, Document Management System).

 

What we offer

 

It’s a brilliant opportunity for someone with the right talents.

Grifols understands you want a challenging and rewarding career in a critical function such as Diagnostic Regulatory Affairs Specialist IH help you grow professionally.

 

Information about Grifols is available at www.grifols.com. If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.

We look forward to receiving your application.

Grifols is an equal opportunity employer.

 

Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h.

Benefits package

Contract of Employment:  Permanent position

Flexibility for U Program: 2 days remote working per week

Location: Sant Cugat del Vallès.

www.grifols.com

Location: SPAIN : España : Sant Cugat del Valles:SC4