Regulatory Affairs Officer – Medical Devices

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Siemens Healthineers enables healthcare providers worldwide to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. We are a global leader in medical technology, committed to innovation and service excellence. Join a team dedicated to making a tangible impact on global health.

Descripción del Trabajo

We are seeking a diligent and detail-oriented Regulatory Affairs Officer to join our dynamic team in Torremolinos, Spain. This role is crucial in ensuring that our cutting-edge medical devices comply with all local, national, and international regulatory requirements. You will be instrumental in preparing, submitting, and maintaining regulatory documentation, ensuring timely approvals, and contributing to the overall compliance strategy for our diverse product portfolio.

Responsabilidades Clave

• Prepare, review, and submit regulatory documentation for new medical devices and product changes to relevant health authorities.
• Monitor changes in medical device regulations (e.g., MDR, IVDR, national specific requirements) and assess their impact on current and future product lines.
• Act as a liaison between the company and regulatory agencies, responding to inquiries and managing submissions.
• Maintain and update regulatory files and databases, ensuring accuracy and completeness.
• Support internal and external audits by providing necessary regulatory documentation and expertise.
• Collaborate with R&D, Quality Assurance, Marketing, and Legal teams to integrate regulatory requirements into product development and commercialization processes.
• Provide regulatory guidance and training to internal stakeholders.
• Assist in the development and implementation of regulatory strategies for new product launches and market access.

Habilidades Requeridas

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Minimum of 2 years of experience in Regulatory Affairs within the medical device industry.
• Strong knowledge of EU Medical Device Regulation (MDR) and other relevant international standards (e.g., ISO 13485).
• Proficiency in preparing and submitting regulatory dossiers.
• Excellent written and verbal communication skills in English and Spanish.
• Strong attention to detail and organizational skills.
• Ability to work independently and as part of a cross-functional team.

Cualificaciones Preferidas

• Master’s degree or higher in Regulatory Affairs.
• Experience with IVDR and other global medical device regulations (e.g., FDA 510(k), Health Canada).
• Familiarity with electronic submission systems.
• Experience in risk management and quality management systems for medical devices.

Ventajas y Beneficios

• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness benefits package.
• Opportunities for professional development and career growth.
• Flexible working arrangements (where applicable).
• Access to innovative technologies and a collaborative work environment.
• Company pension scheme.
• Employee assistance program.

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