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An Exciting Career Opportunity With Advena Limited in the UK

Due to continued growth Advena are seeking to add to our team of regulatory specialists, we have a new position available for those who meet the criteria outlined below;

Role Title:

QMS & Medical Device Regulatory Consultant.

Location:

Office Based in Warwick, United Kingdom.

Rewards:

Competitive salary.

About Us:

Advena is essentially two companies; Advena Limited (UK) and Advena Limited (Malta), the UK business is based at our offices in Warwick. Both companies are expanding medical device consultancy businesses. As a group we specialise in supporting small to medium sized medical device manufacturers and start-ups, to achieve EU and US FDA regulatory compliance.

Summary:

This is an exciting time to join Advena as a Regulatory Consultant within our small team of regulatory specialists, to primarily work on preparing technical documentation and files for submission for audit by Notified Bodies.

As a key member of our team you will manage your own workload while also providing support and guidance to the junior team members, helping them gain valuable experience to grow and develop with Advena.

This exciting opportunity will allow you to use your relevant regulatory expertise to help develop our worldwide client base, in particular guiding our clients through the transition from MDD/IVD to MDR & IVDR.

Essential Job Functions:

You may be involved in the following activities as part of your day to day responsibilities:

  • Preparing, reviewing and approving data elements for use in regulatory technical files in accordance with EU or US FDA requirements for medical devices and IVD’s.
  • Providing on-going regulatory advice and guidance, in an expert capacity, to all clients and junior members of the team.
  • 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.
  • Comply with all company policy and procedures.

 Requirements:

  • Substantial regulatory experience with a medical devices background is essential.
  • You must have substantial experience in the compilation and review of Class I, IIa, IIb and III technical documentation, in addition experience with 510k file compilation and submission to FDA.
  • You will be required to compile clinical data, post market information/data for writing up Clinical Evaluations in line with the requirements of the revised MDD Annex X, MEDDEV 2.7/1 Rev 4 and in line with the requirements of the MDR/IVDR.
  • Risk analysis & risk management activities to ISO 14971.
  • Implementation of various standards, directives, regulations relevant to compliance to EU MDD/IVD, MDR/IVDR and ISO 13485.
  • Comprehensive understanding and Implementation of ISO 13485, FDA 21 CFR Part 820 and MDSAP into quality management systems from inception and to upgrade existing systems.
  • Have good interpersonal and communication skills and be a team player.
  • Attention to detail is extremely important as is the ability to work in a fast paced exciting and deadline driven environment.

Applications:

If you are currently engaged in the activities of a Regulatory Consultant or are ready for a step up and can demonstrate you meet the criteria outlined here, we would love to hear from you.

To be considered for this exciting position, please ensure your application is submitted by Friday 20th, December 2019.

Please note we are currently not accepting applications via agencies.

Job:

Regulatory/QMS.

Primary Location:

Warwick, United Kingdom.

Schedule:

Full-time.

Come Visit Advena at MEDICA 2019

Advena will be located in Hall17, Stand 17B16 – 7 at this important show in Dusseldorf, from 18th to 21st November 2019.

We will be delighted to meet existing and prospective clients during this trade show.

To meet one of our team we would encourage you to email us for an appointment, well in advance to ensure we are available.

Please contact us at info@advenamedical.com

At this show the following Advena team members will be in attendance:

Anthony Kirby: Managing Director (Advena Malta)

Kirsty Ostle: Managing Director (Advena UK)

If you are planning to visit Advena at MEDICA please order your tickets now and avoid the on-site registration process. To register,  visit this link

Further details about MEDICA 2019 may be found at this link

An Exciting Career Opportunity With Advena Limited in Malta

Due to continued growth Advena Limited are seeking to add to our team of regulatory specialists, we have a new position available for a person who can meet the criteria outlined below;

Role Title:

Regulatory Associate – Medical Devices

Location:

Office Based in Swatar, Malta

Rewards:

Competitive salary.

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, 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 intermediate but crucial role 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 that must be carried out that underpin our activities.

As a Regulatory Associate, 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.

This exciting opportunity will allow you to use your relevant regulatory expertise to help develop our worldwide client base, in particular in guiding our clients through the transition from MDD/IVD to MDR & IVDR.

Essential Job Functions:

You may be involved in the following activities as part of your day to day responsibilities:

  • Preparing, reviewing and approving data elements for use in regulatory technical files in accordance with EU requirements for medical devices and IVD’s.
  • Providing on-going regulatory advice and guidance to all clients.
  • 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.
  • Comply with all company policy and procedures.

Requirements:

  • Some regulatory experience with a medical devices background is preferred. However this role would suit a university graduate, majoring in bio-mechanical engineering.
  • You will preferably have some experience with the requirements of medical device Class I, IIa, IIb and III technical documentation.
  • You will be required to compile clinical data, post market information/data for writing up Clinical Evaluations in line with the requirements of the revised MDD Annex X, MEDDEV 2.7/1 Rev 4
  • Risk analysis & risk management activities to ISO 14971.
  • Implementation of various standards and directives relevant to compliance to EU Medical Device Directive 93/42/EC and ISO 13485
  • Have good interpersonal and communication skills and be a team player.
  • Attention to detail is extremely important as is the ability to work in a fast paced exciting and deadline driven environment.

Applications:

If you have a keen interest in technical documentation and in medical devices and would be interested in a career as a regulatory associate, 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 by 30th September 2019, for those selected for an initial interview, these are currently planned to be held week commencing the 7th October 2019.

Job:

Regulatory/QMS.

Primary Location:

Swatar, Malta.

Schedule:

Full-time.

Please note we are currently not accepting applications via agencies.

Medical Device Reclassifications or Up-Classifications: Devices that Currently do not Require a CE certificate

There are several devices that currently do not require a CE certificate under the Directives, which will need certification under the EU MDR by 26 May 2020 for continued market access. This may be due to up-classifications (e.g. some software that is currently Class I under MDD but are Class IIa or higher under MDR) or due to changes in the scope of the legislation (e.g. devices that contain non-viable derivatives of human tissues or cells, which are covered by MDR, but outside the scope of current device directives).

If you have any such devices within your portfolio and need assistance in upgrading your files and submission to your notified body, please do not hesitate to contact us.

Email: info@advenamedical.com

Medical Device Regulation (MDR) EU Regulation – Class I Reusable Surgical Instruments

Manufacturers of Class I Reusable Surgical Instruments must now obtain a CE certificate under Annex IX Chapters I & III or Annex XI – Part A (limited to the re-usability aspects, as appropriate) by no later than May 26th, 2020 for these devices.

Failure to do so will exclude them from placing these devices on the EU market from May 26th, 2020 onwards or until you achieve CE certification.

To be clear your current medical device registration (MDD) will become invalid on May 25th, 2020. You must act now if you wish to continue to CE mark and supply these devices.

Remember, while Notified Body CE certification is limited to the aspects concerning the reusability of your devices, all your technical documentation must also be upgraded to comply with the MDR and Advena can assist with the technical file upgrades.

Time is now running out and there are only two Notified Bodies currently designated to MDR (BSI UK & TUV SUD). The EU Commission have promised that more will be available by the end of the year, therefore, it makes sense to begin the process of upgrading your technical documentation/files now. So, you need to instruct your regulatory team to begin preparations, if you don’t have the resources internally please do not hesitate to contact us, as mentioned above, we can help!

Email: info@advenamedical.com

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