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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

UKCA: UK’s Proposed ‘CE Mark’ Replacement

In February 2019, the MHRA published guidance on the use of the ‘UKCA’ (UK Conformity Assessed) mark in the event of a ‘No-Deal’ Brexit. The guidance stated that the UKCA mark would not be recognised on the EU market and manufacturers would still be required to obtain CE marking for products to be placed on the EU market and that the UKCA mark will need to be applied in the following situation(s);

  • The product is for the UK market.
  • The product requires mandatory third-party conformity assessment.
  • The conformity assessment for the product has been carried out by a UK conformity assessment body (a UK-based notified body or recognised third-party organisations).

The guidance also stipulates that “in the majority of cases you will still be able to use the CE marking if you are selling goods on the UK market after the UK leaves the EU. The CE marking will only be accepted in the UK for a limited time after Brexit”, however, this guidance was withdrawn on 30th January 2020.

With the deadline for the end of the 1-year transition period fast approaching, it is still unclear whether the UK government intends to put these measures in place. As a result, manufacturers are urging the UK government to provide more details and guidance on these plans to ensure they have adequate time to prepare to affix the UKCA mark on their products.

It is understood that the UK government is not likely to announce details of the new UKCA mark until a mutual decision has been made as part of the ongoing UK-EU trade negotiations. Understandably, concerns are growing as to the relatively short time left to put any new UK requirements in place to ensure compliance before the end of the year, although we have been made aware from a reliable source that the MHRA is currently reviewing the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

We will keep you posted with any updates as soon as we receive them.

Advena Limited – Statement on COVID-19

The COVID-19 pandemic is rapidly affecting lives and how businesses operate worldwide. Increasingly governments are introducing stricter measures to protect public health, which ultimately impacts on the movement of Advena Limited’s employees’, the individuals we trust to implement our regulatory obligations.

During these difficult times the safety and well-being of our families, friends and colleagues are our highest priority.

Advena Ltd a leading EU Authorised Representative and provider of regulatory & QMS consultancy in the medical devices industry are committed in their support of this important industry and in the part played in assisting the availability of health care products for the EU market. However, we must also comply with any restrictions applied by both the Maltese and UK governments and also implement our own COVID-19 pandemic crisis plans based on the further recommendation given, e.g. protection of employees at high-risk and working remotely, including quarantine and social distancing. These measures will undoubtedly provide challenging circumstances; however, we remain resolute in our ability to continue to meet our obligations to regulation and clients.

Therefore, while our service may experience some delays, we do not expect to suspend operations, temporarily or otherwise.

During this difficult period in our history we ask that you be patient and bear with us and above all stay safe.

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