We have an amazing opportunity for a motivated regulatory affairs individual to join Quality Assurance and Regulatory Affairs team for an established medical device company based south of London. The role is a flexible hybrid of remote and onsite working.
As the Regulatory Affairs Associate, you will be providing significant assistance to the Regulatory team working on an extensive medical device portfolio. You will be supplying regulatory input and data, and assisting in compliance with standards and medical device regulations worldwide. Your main duties and responsibilities are as follows:
- Preparation of documentation for the filing of regulatory submissions to US FDA;
- Preparation of submission packages for European agencies and other International Authorities
- Maintaining regulatory information systems
- Compliance to global regulatory requirements and company policies
As the ideal candidate, you will have experience in a Regulatory Affairs role within a Medical Device Organisation and experiences dealing directly with Regulatory Authorities. You must be familiar with Quality System concepts, practices and procedures such as ISO13485 and MDD and MDR. You will also have some experience working across export markets and dealing with international distributors.
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