Regulatory Affairs Engineer
hace 15 horas
About the Role
Sinclair is seeking a Pre-Market Regulatory Affairs Engineer to join its Corporate Regulatory Affairs Team in Esplugues del Llobregat (Barcelona). This role will ensure regulatory requirements are met for new product development and design changes to established legacy devices.
Key Responsibilities
- Collaborate with Research and Development and other business departments to ensure design and development processes contain the correct regulatory requirements and supporting evidence.
- Prepare dossiers and technical documentation for product submissions worldwide, and manage the submission with the regulatory agency.
- Contribute to providing Regulatory solutions to business requirements and changes to the regulatory landscape.
Your Skills & Experience
To succeed in this role, you will have:
- A minimum of 5 years' experience in Regulatory Affairs (Pre-Market) within a Medical Device company 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., EU, USA, 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.
What We Offer
You will be offered a salary of approximately €60,000 per annum, depending on your level of experience. Additionally, you will benefit from:
- A competitive benefits package.
- Ongoing training and professional development opportunities.
- The chance to work with a dynamic team in a fast-paced industry.
About Us
We are Sinclair, a leading company in the medical device industry. Our team is dedicated to delivering innovative products that improve patient outcomes.
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