Regulatory Affairs - Medical Devices

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.

Place of work