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New Vacancies at Advena UK

We are excited to announce, that  Advena UK are expanding!

We are looking to recruit two highly experienced regulatory professionals to join the UK team.

Our role is to support small/medium sized medical device manufacturers, & start-up organisations to achieve EU/UK/US regulatory compliance.

The positions currently are:

Medical Device Regulatory Consultant/Specialist (IVD/IVDR)

Salary: £45-£70k depending on experience

Job specification link: Advena Ltd UK V02 IVDR

Medical Device Quality and Regulatory Consultant (MDD/MDR)

Salary: £45-£55k depending on experience

Job specification link: MDD Vacancy

 

 

Please email me to discuss the opportunities available.

Kind regards,

Helen George

Business & Project Manager, UK

Published: July, 2021

 

 

 

Due to Continued Growth, Advena Limited in Malta are Looking for a Regulatory Intern.

Due to our continued expansion in Malta, Advena Limited are seeking to add a Regulatory Intern to our team of regulatory specialists, this is an exciting opportunity for an individual who has an interest in medical devices and new medical technology, we offer ‘on the job’ training to the successful applicant who over time would progress to Regulatory Associate as a steppingstone into consultancy.

We invite applications from students in their final year or those who have recently graduated.

Initial Responsibilities:

  • Gain an understanding of Regulation (EU) 2017/745 & (EU) 2017/746.
  • Basic technical documentation reviews.
  • Regulatory administration.
  • Scheduling.
  • Research.
  • Liaising with external regulatory authorities to ensure approvals are obtained in line with project schedules.
  • Performing all activities in compliance with relevant Quality Systems standards and specifically with ISO 13485.

Applications should be majoring in Engineering or comparable/similar disciplines.

Role Title:

Regulatory Intern – Medical Devices

Schedule:

Full-time.

Location:

Office Based in Swatar, Malta

About Us:

Advena Limited is essentially two companies; Advena Limited in the UK and Advena Limited in Malta. Both companies are expanding medical device consultancy business, the UK business primarily has a client base from within the EU (including the UK), while our office in Malta has a client base who are located outside the EU. As a group we specialise in supporting small to medium sized medical device manufacturers and start-ups, to achieve regulatory compliance and CE Mark their medical device products.

In Summary

This is an exciting time to join Advena, in this entry level role that has plenty of potential, within our small team of regulatory specialists, to primarily work on assisting with the preparation of technical documentation and files for submission for audit by Notified Bodies. However, there are also business administration duties, including our quality management system, that must be carried out that underpin our activities.

As Regulatory Intern, you will be an integral member of our team, you will be guided by senior team members, providing you with the requisite support and guidance, enabling you to gain valuable experience to grow and develop with Advena.

Applications

If you have a keen interest in technical documentation and in medical devices and would be interested in a career in Regulatory Compliance, with the long-term goal of becoming a consultant and can demonstrate an understanding of the criteria outlined here, we would love to hear from you.

Applications must be submitted to Mr Anthony Kirby by email to anthony.kirby@advenamedical.com including a copy of your CV. by 30th June 2021, for those selected for an initial interview, these are currently planned to be held mid-July.

Advena Ltd UK, Instrumental in Forming a New Trade Association: – UK Responsible Person Association (UKRPA).

Advena Limited UK, in our continuing endeavour as a leading UK based regulatory consultancy organisation are at the forefront of establishing a new trade association in the UK. Specifically aligned with the UK’s medical device regulations and with direct communication links to the Medicines and Healthcare products Regulatory Agency (MHRA).

This new trade association will assist Advena in obtaining key regulatory information in advance of publication and consequently Advena are significantly better placed to advise those clients who require the services of a UK Responsible Person (UKRP).

Non-UK based medical device manufacturers must now appoint a UKRP as part of the regulatory compliance process for UK market access. For further details regarding this service please contact Advena Ltd UK.

Email: ukrp@advenamedical.com

Quality Management Systems (QMS) Under the MDR

Regulation (EU) 2017/745 (MDR) requires manufacturers of devices, other than investigational devices, to establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and such that it is proportionate to the risk class and the type of device. Article 10 (9) of the MDR goes into further detail.

Manufacturers should be looking closely at their QMS to ensure it meets the requirements of the Regulation. A QMS to ISO 13485:2016 will cover most of these aspects, but not all. Therefore, it will be vitally important to carry out a review of your QMS.

The implementation of the MDR to 26th May 2021 is not far away, so please use this time wisely.

If you don’t have the resources internally or locally, remember Advena have a team of consultants who can help and should you need our assistance please do contact us and we will happily discuss and provide you with a quotation to review your QMS. If you need to implement a new QMS, we can also quote for this.

Email us at: Info@advenamedical.com

The Deadline for the MDR Transition is Fast Approaching – Are You Prepared?

Hopefully, the answer is yes. May 26th, 2021 is only a matter of months away and time is short.

Please remember Advena Ltd is well placed to help those clients who do not have the necessary resources, either internally or local to their operation. We have a team of consultants, based in our offices both in the UK and Malta with a wide range of experience across the whole platform of device classifications.

Whether you need a new technical file creating or an analysis of your existing documentation and what must be done to upgrade to the MDR, we have a service that can help.

If you just need certain sections of your documentation creating or reviewing, such as Risk Management or the critically important Clinical Evaluation Report section, we can also help, or perhaps with another sections of your technical files.

Remember, you will also need to update device labelling, packaging, IFU’s etc. and while EUDAMED is not fully operational, applicable devices must be registered the competent authority where your Authorised Representative is based, there is so much to do in these remaining few months, do not delay, get in touch if you need assistance.

For further details and a quotation, Email us at: info@advenamedical.com

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