Job Details: Senior Regulatory Affairs Engineer (Pre-Market)
Vacancy Name: Senior Regulatory Affairs Engineer (Pre-Market)
Vacancy No: VN179
Employment Type: Full-Time
Location: Esplugues del Llobregat (Barcelona)
The RoleSinclair is currently looking for a Pre-Market Regulatory Affairs Engineer at its offices located in Esplugues del Llobregat (Barcelona).
Working within the Corporate Regulatory Affairs Team, the Pre-Market Regulatory Affairs Engineer ensures regulatory requirements are met for new product development and design changes to established legacy devices.
Reporting to the Team Leader Registration and Regulatory Affairs Engineer, the position holder assures the design and development processes contain the correct regulatory requirements and supporting evidence.
Working closely with Research and Development and other business departments, the position holder will also ensure the type of testing certification such as electrical compatibility and compliance to product-specific standards and directives.
This assures the integrity of the design history file and technical documentation as a precursor to country-specific registration(s).
This position provides and contributes to the Regulatory deliverables from internal Research and Development projects, contributing to providing Regulatory solutions to business requirements and changes to the regulatory landscape.
This position provides operational Regulatory input and guidance to cross-functional teams, ensuring compliance to the UK, European, USA, and International country-specific legislations.
This position will prepare dossiers and technical documentation for product submissions worldwide and will be responsible for the management of the submission with the regulatory agency.
Your Skills & Experience – Do You Have What it Takes?Essential: 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.Fluency in written and spoken English.Ideally, if you also have experience with cybersecurity or AI.A bit about you – do you fit this description?Personal responsibility.Able to work autonomously and proactively.Communication, impact and influence.Analytical and critical thinking capacity.Time management, organization and planning.Work accurately with attention to detail and promote quality culture through the business.Orientation towards achievement.Adaptability and openness to change.Ability to learn.Integrity and professional ethics.
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