Hobson Prior are currently looking for a Regulatory Affairs Manager to join an international healthcare organisation on a contract basis. Our clients mission is to offer medical solutions in order to change people's lives.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will offer regulatory support to the R&D Project teams with the applicable Design Control processes.
• To deliver team members ad hoc specific education.
• Offers qualification and classification of the development object and related submission strategy.
• To raise project related regulatory issues
• Review of labelling.
• Assemble the documents and the project deliverable (or coordinate the activities) for the preparation of world-wide registration and resolution of possible conflicts.
• Administration of Product declarations, Certificates and other, similar documents.
• Define and implement necessary processes, strategies and SOPs to manage the interfaces within the assigned area.
• Ensure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interest.
• To educate staff members of R&D and Portfolio Management on regulatory related topics.
• You will support for specific topic/questions.

Requirements:

• Bachelor or Master Degree in Life Sciences.
• At least 5 years of experience as a Regulatory Affairs Manager in IVD Instruments electrical medical devices as a plus.
• At least 5 years of experience with Development of IVD Devices Hardware and Software of IVD Instruments as a plus.
• Experience in industry.
• Experience in supporting development projects.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.