Join our team

We are looking to appoint a Regulatory Affairs Manager in the UK to be the main liaison with third party consultants and the notifying body to help us achieve the IVD certification necessary for our sensor as a medical device, and to help us implement an internal Quality Management System.

This is a key hire for the organisation and as such the right candidate must be an experienced Regulatory Affairs Manager Innovative Medical Devices, with experience in submission & publishing. In the role you, will be responsible for regulatory team within the UK.

Responsibilities
Manage submissions and other regulatory aspects during the development phase of our medical device, including but not limited to Clinical Trial Applications, Neonatal Investigational Plans, Scientific Advice in the UK.
Manage both centralised and/or decentralised submissions for approval and maintenance of marketing authorisations for our device in the UK.
To develop regulatory strategies during development, approval and post approval phases for submissions to UK Competent Authorities.
To obtain regulatory approvals and other feed-back or decisions from UK Authorities during further development of our device.
To obtain registrations for innovative medical devices, in the UK and to ensure that the registrations for existing marketed products are maintained.
To provide regulatory guidance to cross-functional teams.

Requirements
Substantial UK regulatory affairs experience (at least 5 yrs), preferably with experience also in the EU.
Experience in managing development work, new submissions and maintenance work will be a distinct advantage.
Experience with relevant medical device related aspects in the neonatal setting.
Innovative Medicine experience in the neonatal nutrition area is also a significant advantage.

Key Accountabilities
• Conduct audits at clients’ sites and remotely, in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
• Work alone or lead audit teams as appropriate, enhance client satisfaction and ensure compliance with standards and regulatory requirements
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
• Be a Final Reviewer and Certification decision maker for IVD audits.
• Develop and maintain strategic growth plans for IVD services, working with the Head of Sales and Marketing, Operations managers and Academy Manager to ensure all aspects of the customer journey are covered.
• Support UKCA Medical devices Certification Manager with technical and procedural requirements for IVD UKCA certification to ensure SGS compliance and participate in Regulatory Body audits in relation to IVD to ensure we maintain our Approved Body Status.
• Attend meetings with the Global IVD manager and certification managers from other regulatory schemes which are managed elsewhere in the SGS network.
• Ensure appropriate training is provided to IVD auditors and required competent resources are available to deliver on the scheme requirements.
• Support SGS Academy by delivering training courses to the public in person virtually as requested.

Qualifications
A minimum of 4 years ‘hands-on’ professional experience of designing, manufacturing or testing IVD medical devices:

• 2 years of the 4 years from working within a formal Quality Management System or working in Quality Management /Regulatory Affairs.
• A university degree or equivalent qualification in relevant sciences such as: Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Physics, Biophysics, Material Science Biomedical Engineering, Mechanical, Electrical or Electronic Engineering, Computer & Software Technology.

Knowledge Of
• IVD medical devices and Medical IVD device management systems.
• Directive 98/79/EC equivalent to UK MDR 2002 as amended for UKCA, ISO 13485, MDSAP.
• IVD Medical Device Standards.

In Addition
• Experience of working under own initiative and in planning and prioritising workloads.
• Full driving licence for use in the UK.
• Good English written and verbal skills.
The Following Attributes Would Be Desirable, But Not Essential
• Registered IRCA lead auditor, or equivalent registration under other recognised body.
• Experience in delivering training and in engaging and working with people in all levels of an organisation.
• Experience of reviewing audit packs.
• Review of technical documentation.

Additional Information
This position is ideally suited to an existing Notified Body IVD Lead Auditor looking to develop their career further by progressing into a more managerial role with less time travelling and auditing at clients’ facilities.

Apply Now for full consideration, you can be sure that your application will be treated confidentially and impartially, and you will always receive an update within 10 business days.

Please send your cv and cover letter to info@preemiesensor.com with the reference