Senior Manager International Regulatory Affairs-EMEA
Permanent / Full Time
Industry leading remuneration package to include company equity, annual bonus scheme, 10% pension, private healthcare and more!
Illumina are the leading company in the drive to bring the power of genomics and next generation DNA sequencing (NGS) into human healthcare and diagnostics. With the industry leading NGS platform and a suite of sample to answer solutions, Illumina promises to change the way healthcare is administered by giving the power of the genome directly to clinicians and patients.
As part of this vision, Illumina are building a robust Quality and Regulatory Affairs (RA) function in EMEA to streamline the registration and approval of IVD, Medical Devices and platform technologies. We are looking for a committed and experienced Regulatory Affairs specialist, with a strong knowledge of IVD/Med Device registration in EMEA, to lead the RA function in EMEA. This is an exciting opportunity for someone wanting to get involved in developing an RA function for Illumina in EMEA.
Professional interaction with internal colleagues at non-EU based business lines to support CE registration of products so that they can be placed on the market in EU/EEA. Potential professional interaction with National Competent Authorities within any of the 28 EU member states and the 3 additional members in the EEA in connection with the requirements of the IVDD 98/79/EC and MDD Directive 93/42/EC for product registration / notification and Medical Device Vigilance.
- Registration of new product notifications, performance evaluations and product withdrawals as required with the UK Authorities (MHRA) for non-EU manufactured Medical Devices including IVD in accordance with the IVD and MDD Directives.
- Ensures that the notification system is always up to date and in line with corporate policies and procedures.
- Ensures the notification information is communicated effectively and in a timely manner to all Illumina business lines located outside the European Union, and Illumina personnel inside the European Union as applicable and appropriate.
- Responsible for organizing payment of notification fees to UK Authorities.
- Interaction with the Illumina non-European Union based business lines to ensure optimization of notifications made with the UK Authorities (MHRA)
- Monitoring, coordinating and reporting on a monthly basis, notification and regulatory metrics which will include (but not limited to) product notifications, medical vigilance issues, field safety corrective actions.
- Co-ordinates all the details of notification in the European Union to support product launches.
- Supports research and development, marketing, business development or any other corporate effort, as necessary.
- Travel within Europe as required. Travel as required to Illumina sites outside the European Union for which the Authorized Representative Manager is the legal representative (EU Authorized Representative) for within the European Union.
- Eventual supervision of a small team of professionals (EU Authorized Representative Assistant/s)
- Has responsibility to ensure financial payments are made with respect to registration of Medical Devices completed with MHRA. Responsibility for running of the EU Authorized Representative functional group. Reports directly to local management and functionally to the Global Director Vigilance Programs and International RA Director.
If you are a hands-on RA specialist with direct exposure of CE registration of IVD and/or Med Devices in EMEA and are looking for a chance to build out a robust function in a leading multinational biotech company, then this role is worth consideration.