Senior Regulatory Affairs Specialist

hace 2 semanas

Barcelona, Barcelona, España Com si fos ahir A tiempo completo

Job Title:
Senior Regulatory Affairs Engineer

About the Role:
We are seeking a highly experienced Senior Regulatory Affairs Engineer to join our team at Com si fos ahir. As a key member of our Corporate Regulatory Affairs Team, you will be responsible for ensuring that our medical devices meet the necessary regulatory requirements for new product development and design changes to established legacy devices.

Key Responsibilities:
• Provide expert knowledge and guidance on the interpretation and implementation of regulatory legislation and guidelines for medical devices, particularly in the UE, EEUU, and Canada territories.
• Prepare technical documentation and submission packages (STEDs) for the filing of premarket global regulatory submissions in line with company strategy.
• Establish and maintain regulatory information systems, technical documentation files, and routine reports.
• Collaborate with global Regulatory Affairs teams to understand existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures.
• Ensure regulatory compliance to global requirements and company policies.
• Support new product development activities.
• Review documents and product changes for regulatory submission impact.

Your Skills and Experience:
We are looking for a candidate with a minimum of 5 years of experience in Regulatory Affairs (Pre-Market) within a Medical Device and with active medical devices (energy devices).
Essential qualifications include:
• Specific knowledge of active devices and associated standards (e.g., IEC 60601/IEC experience with the Medical Device Regulation.
• Knowledge of other regulatory legislation and guidelines, e.g., UE, EEUU, and Canada regulations.
• Excellent attention to detail when reviewing and preparing documentation.
• Organised, target-orientated, flexible, good time management skills.
• Strong written and oral communication skills.
• Fluency in written and spoken English.

About You:
We are looking for a team player with excellent communication skills, who is able to work autonomously and proactively. You should have a strong analytical and critical thinking capacity, with a focus on quality and attention to detail. If you are a motivated and adaptable individual with a passion for Regulatory Affairs, we would love to hear from you.

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