Regulatory Specialist

If you've been looking for a company allowing you to work remotely, this is it.

We are looking to hire a Regulatory Specialist permanently for a Medical Device manufacturer.

Our client, a leading medical device company, is seeking a Regulatory Specialist with expertise in FDA regulations, MDR, and technical files. In this role, you will play a pivotal role in ensuring regulatory compliance and driving the success of their innovative product range.

Here's a sneak peek into what your role will entail:

- MDR Remediation: take ownership of 5-8 technical files and ensure they are remediated to meet the MDR.

- Cross-Functional Collaboration: work closely with various teams to fill in any gaps in the tech file summary. Confidently communicating with individuals to ensure timelines are met.

- Quality Assurance Support: You will act as support to the QA team on audits for product recalls or regulatory related issues, so a basic understanding of QA will serve you well in this role.

To thrive in this role, you'll need:

• In-depth knowledge of FDA regulations and ISO13485.
• Strong communication skills and the ability to proactively engage with various teams across the organisation.
• 3 years of experience in regulatory affairs, with a passion for learning and growing within the field.

Please apply with an up to date CV and I will be in touch if successful.

Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.