Regulatory Affairs Specialist: Global Medical Device Compliance
hace 3 días
Company Overview: A leading organization within the Antal International Network is seeking an experienced Regulatory Affairs Professional to join its expanding Medical Device Unit.
Salary: The estimated annual salary for this role is around €60,000 - €80,000, depending on experience and qualifications.
Job Description: As a Regulatory Affairs Specialist, you will be responsible for developing and implementing global regulatory strategies for the timely approval of medical devices across multiple regions. This includes coordinating and preparing regulatory documentation, working closely with notified bodies and regulatory agencies, and ensuring compliance with international standards.
Key Responsibilities:
- Develop and implement global regulatory strategies for the timely approval of medical devices
- Coordinate and prepare regulatory documentation, including technical files
- Work closely with notified bodies and regulatory agencies to ensure compliance with international standards
- Support business development and marketing activities related to medical devices
- Manage and improve quality management systems (QMS) to ensure continuous compliance and effectiveness
Required Skills and Qualifications: To succeed in this role, you will need:
- A degree in biological sciences, pharmaceutical sciences, or biomedical engineering
- At least 2 years of experience in Regulatory Affairs within the medical device sector
- Familiarity with Quality Assurance procedures for medical devices
- Experience in Research & Development or Project Management is a plus
- Proficiency in English and Spanish
Benefits: As a valued member of our team, you can expect:
- A permanent contract
- Flexible working hours, with Fridays ending at 3:30 PM
- A hybrid work model (Barcelona-based)
- An exciting variety of projects and growth opportunities
- Personal development programs and English lessons
- A diverse and inclusive work environment with employees from over 15 nationalities
- A comprehensive well-being program focused on physical, emotional, and psychological health
Why Choose Us? We offer a company culture built on passion, flexibility, commitment, quality, and camaraderie. We are an equal opportunity employer and welcome applications from candidates who are eager to contribute to the growth of a leading organization and help drive global healthcare innovation.
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