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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