Regulatory Affairs Manager Global Medical Device/IVD company- Oxford

Oxford MediStress is developing a patented in vitro diagnostics test that measures immune status through a simple, rapid pinprick blood test. Working closely with its sister company, Seroxo, the team is developing clinical applications in areas ranging from COVID to sepsis to cancer to stress measurement.

In order to strengthen our team, we are looking for an experienced professional to join us as the Regulatory Affairs Manager.

Responsibilities:

·         Responsible for meeting the regulatory requirements for the approval of in vitro diagnostic products and medical devices during the whole product development process

·         Ensuring the compliance of the technical documentation of the products according to the regulatory requirements for IVDs and medical devices

·         Leadership in establishing a company-wide Quality System to meet relevant ISO standards

·         Monitoring all products for any risk potential

·         Support of international registration submissions and in the preparation and execution of audits

·         Interdisciplinary cooperation with Product Managers through the entire lifecycle in regulatory terms

·         Communication of new regulatory approval requirements to R&D as well as Product Managers and support of implementation

·         Monitoring of any product-related regulatory content, information and release effects

·         Performing conformity assessment for the products and taking part in the preparation of the declaration of conformity

·         Support and consulting for R&D and Product Managers in the interpretation of regulatory requirements

·         Experience of writing and reviewing regulatory documents, including ability to interpret and accurately summarise complex scientific data for inclusion in regulatory packages

·         Experience of interacting directly with regulatory agencies, in particular the MHRA

·         Inputting into the design of studies to meet regulatory requirements

·         Interaction with sister company, Seroxo

Requirements:

·         BSc or MSc in Life Science studies, or corresponding industry experience

·         3-4 years of experience in RA (International products/markets) in IVD/Medical Device/Technology field

·         Knowledge of IVDR, MDR and UK regulatory requirements

·         Knowledge of US FDA requirements a benefit

·         Product classification; Definition of applicable standards; Conformity assessment procedures

·         MS-Office knowledge essential

·         Excellent skills in written and spoken English essential

What is in for you:

·         Competitive remuneration and benefits package

·         Opportunity to work and grow with dynamic Oxford spin-out

Please note we can only accept applications from candidates who are able to work in the United Kingdom without visa sponsorship.

To apply, send covering letter and CV to: admin@oxford-medistress.com

Keywords: in vitro diagnostics, medical devices, regulatory affairs, RA, global projects, submissions, regulations, management, IVDR, MDR, MDD.