Regulatory Affairs Specialist
hace 6 días
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.
We are looking for a Regulatory Affairs Specialist to join the Technical department at Grifols Movaco SA.
The main mission will be to provide support related to the regulatory functions and management of medical devices from external suppliers that are imported and distributed by Grifols Movaco SA.
What your responsibilities will be:
- Review the content of the processes, instructions, and records that are part of the quality system related to compliance with applicable regulations and directives.
- Coordinate and supervise the obtaining of the documentation certifying products and their manufacturers, importers, and/or distributors.
- Review the documentation certifying products and their manufacturers, importers, and/or distributors.
- Prepare, review, follow up, communicate, and archive the documentation generated/required for the import and/or distribution process of medical products.
- Carry out the necessary communications for the marketing and commissioning of medical devices.
- Provide the department with regulatory advice to ensure compliance with current regulations.
- Maintain and manage the communications made in the national registry.
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 Life Sciences field is preferred.
- Knowledge and experience in regulatory processes for medical devices, as well as the ability to coordinate and supervise the obtaining of the certifying documentation.
- 2 years of experience in a similar role within the pharma industry and/or medical devices.
- Advanced level of English.
- User of Microsoft Office tools, especially Excel.
- You are meticulous and detail-oriented.
- You have excellent communication and teamwork skills, as well as initiative and results orientation.
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.
Benefits package:
Contract of Employment: Permanent position
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