IVD Regulatory Affairs Manager – Remote role

Job Description

Job title: IVD Regulatory Affairs Manager – Remote role

Company: NonStop Consulting

Job description: Regulatory Affairs Manager – A Great Place to Work!

A leading organization in the IVD industry has an exciting opening for a Regulatory Affairs Manager. Join a team of high-level professionals and work on high-level projects, while enjoying the flexibility of a remote position.

As the Regulatory Affairs Manager, you will have the opportunity to work in a niche within a niche, focusing on IVD (In-Vitro Diagnostics) products. You will play a crucial role in ensuring compliance with regulatory standards, including IVD, FDA, and 510k requirements.

What makes this role even more appealing is the chance to work independently, taking ownership of projects and making confident and pragmatic decisions. You will also need to have a good understanding of the business side of the industry, allowing you to navigate through complex data and review technical documents with ease.

Requirements:
– 5-10 years of experience in the IVD, specifically in Regulatory Affairs
– Fluent in English, with excellent communication skills
– Experience with CDX (Companion diagnostics) is highly desirable
– Familiarity with QMS (Quality Management System) and GMP (Good Manufacturing Practices) expectations, including ISO13485 & 21CFR820
– Knowledge of IVDD (In Vitro Diagnostic Device) and pending IVDR (In Vitro Diagnostic Device Regulation)

If you are someone who is responsible, takes ownership, and thrives in a high-level professional environment, this position is perfect for you. The organization offers a great work-life balance, a supportive work culture, and a competitive compensation package.

Do you have any disability or condition that could affect you in the application and interview process? Please feel free to share this information as part of your application, including any necessary adjustments you might need, so we can help make the process easier for you. We assure you this information will not have any negative effect on the interview process outcome.

About NonStop: We are NonStop, a leading provider of staffing solutions throughout Europe and now also in the US. We’re passionate about connecting talent with opportunity and work non-stop to support our clients in hiring the best talent for their teams. Feel free to pop over to our website, NonStop Consulting (https://www.nonstopconsulting.com), for more information, to browse all our roles, or to let us know how we can help you.

Expected salary:

Location: London

Job date: Sat, 13 Jan 2024 07:02:33 GMT

Apply for the job now!