Medical Device Regulatory Compliance Specialist
hace 3 semanas
About Grifols
Grifols is a global healthcare company that has been improving the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries and regions.
We believe that diversity adds value to our business, teams, and culture. We are committed to equal employment opportunities that foster an inclusive environment.
The Opportunity
We are seeking a Medical Device Regulatory Compliance Specialist to join our Technical department at Grifols Movaco SA.
About the Role
This is a fantastic opportunity for a detail-oriented and results-driven individual to provide regulatory support for medical devices from external suppliers imported and distributed by Grifols Movaco SA.
Your key responsibilities will include:
- Reviewing quality system processes, instructions, and records related to compliance with applicable regulations and directives;
- Coordinating and supervising the obtaining of documentation certifying products and their manufacturers, importers, and/or distributors;
- Preparing, reviewing, following up, communicating, and archiving documentation generated/required for the import and/or distribution process of medical products;
- Carrying out necessary communications for the marketing and commissioning of medical devices;
- Providing regulatory advice to ensure compliance with current regulations;
- Maintaining and managing communications made in the national registry.
Requirements
To succeed in this role, you must have:
- A Bachelor's Degree in Life Sciences;
- Knowledge and experience in regulatory processes for medical devices, as well as the ability to coordinate and supervise the obtaining of certifying documentation;
- At least 2 years of experience in a similar role within the pharma industry and/or medical devices;
- An advanced level of English;
- Familiarity with Microsoft Office tools, especially Excel;
- Excellent communication and teamwork skills, as well as initiative and results orientation.
What We Offer
As a Medical Device Regulatory Compliance Specialist, you can expect a competitive salary range of $80,000 - $120,000 per year, depending on location and experience.
At Grifols, we are committed to maintaining an excellent working environment where employees can develop their careers. Learn more about Grifols at www.Grifols.Com
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