My client is a market leading MedTech manufacturer, specialising in innovative surgical products, based in the heart of the home counties. Due to their exceptional continued growth, we have a superb opportunity for a Regulatory Affairs Engineer to join the team.
As the new Regulatory Affairs Engineer, you will be working closely with the Head of QARA and as a part of an established team of Regulatory and Quality professionals. You will be responsible for International Product Registrations and involved in Technical File creation, maintenance & development, Post Market Surveillance, Customer Complaints and CAPA reporting.
Responsibilities
1. Work with internal departments and external regulators, suppliers, and customers with a broad remit to ensure the ongoing product and systems compliance to the applicable regulations and standards.
2. Work closely with the wider Regulatory team for Product Registrations in International markets.
3. Assist in the maintenance and review of technical product files and assist in the continued transfer to the MDR.
4. Work with the design department to ensure ongoing regulatory compliance of current and new products.
Experience
1. Proven Regulatory Affairs experience in the Medical Device industry.
2. Demonstrable proficiency in international product registrations.
3. Proven experience & knowledge of interpreting and applying standards and regulations.
4. Familiarity with electro/mechanical products, along with an awareness of regulatory implications.
5. Highly desirable experience with medical standards, as well as European and FDA regulations, including ISO 13485, EC 93/42, and MDR.
You will be rewarded with a great salary and benefits including a monthly bonus scheme.
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