A growing organization is looking for an experienced Regulatory Affairs Professional to join its expanding Medical Device Unit. This role presents a unique opportunity to work on innovative projects within a dynamic international environment. Ideal candidates will have a passion for medical device regulations and a desire to take on new challenges.
Key Responsibilities: Develop and implement global regulatory strategies for the timely approval of medical devices across multiple regions, including CE marking, FDA clearance, and PMA.Provide expert guidance to clients on medical device development and regulatory pathways.Coordinate and prepare regulatory documentation, including technical files, for submission to global regulatory authorities.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.Handle regulatory documentation for FDA and MDR submissions and maintain effective communication with global stakeholders.Facilitate internal and external audits and ensure overall regulatory compliance.Requirements: 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.Ability to work on-site 2-4 days per week (Barcelona province).Strong interest in technological innovation, product development, and regulations.Detail-oriented with the ability to manage complex projects involving multiple stakeholders.What the Organization Offers: Permanent contract.Flexible working hours, with Fridays ending at 3:30 PM.Hybrid work model (Barcelona-based).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.A company culture built on passion, flexibility, commitment, quality, and camaraderie.Equal opportunity employer.Candidates who are eager to contribute to the growth of a leading organization and help drive global healthcare innovation are encouraged to apply.
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