Regulatory Affairs Professional
hace 2 días
Job Details: We are seeking a highly skilled Regulatory Affairs Engineer to join our Corporate Regulatory Affairs Team in Esplugues del Llobregat, Barcelona. The successful candidate will play a crucial role in ensuring regulatory requirements are met for new product development and design changes to established legacy devices.
The Role: As a Regulatory Affairs Engineer, you will work closely with Research and Development and other business departments to ensure the design and development processes contain the correct regulatory requirements and supporting evidence. You will also be responsible for preparing technical documentation and submission packages (STEDs) for the filing of premarket global regulatory submissions in line with company strategy.
Key Responsibilities:
- To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices, particularly in UE, EEUU and Canada territories.
- Preparation of 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.
Requirements:
- Minimum 5 years experience in Regulatory Affairs (Pre-Market) within a Medical Device and with active medical devices (energy devices).
- Specific knowledge of active devices and associated standards (e.g., IEC 60601/IEC 62304).
- 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.
About Us:
We are Com si fos ahir, a dynamic and international company offering a competitive fixed salary aligned with the market + variable. Our benefits include medical + dental insurance, hybrid work model, flexible schedule, short Friday, fruit at the office, and more.
Salary: €60,000 - €80,000 per year, depending on experience.
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