Scientific and Process Technology

Regulatory Affairs Manager

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About the job

Are you looking for a new regulatory affairs manager position, with a growing biotechnology company based in San Jose?

Invenia Group is partnering with a leading biotechnology company, that is at the forefront of developing cutting-edge innovative tools and services that accelerate scientific discovery. We are looking for a regulatory affairs manager to join their team in San Jose.

Role responsibilities:

Here you will be responsible for leading regulatory strategies, managing relationships with stakeholders, and executing compliance tasks. You will assess regulatory requirements and develop strategies for submissions to regulatory agencies, this will be related to the approvals IVDs and medical devices.

What we are looking for?

We are looking for someone with a B.S. degree with a regulatory affairs certification or a degree in a scientific discipline. You must have at least 5 years of experience in regulatory affairs within the IVD, medical device, or bio/pharma industry. You must also have experience in preparing and submitting regulatory documents, including 510(k) submissions and international registrations. In-depth knowledge of the technical and scientific principles related to IVD reagent chemistry, medical devices, and CLIA lab certification would also be desirable.

Sound interesting? If you’re looking for a new opportunity to become part of a growing, successful company, where you will not only receive a rewarding career and competitive salary but also an excellent bonus scheme and a range of additional benefits! To find out more, please apply.