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+44 (0) 1926 800 153 info@advenamedical.com

Due to Continued Growth Advena are Seeking to Employ Another Senior Regulatory Consultant.

Job description

Role Title

Senior Regulatory Consultant – Medical Devices

Location

Office Based in Warwick, United Kingdom

Rewards

Competitive salary.

About Us

Advena is essentially two companies; Advena Limited and Advena Medical Limited, both based at our offices in Warwick, UK. Both companies are expanding medical device consultancy business, Advena Limited also has an office in Malta. 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 products.

Summary

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

As a key member of this team you will in essence manage your own work-load 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 would allow you to use your 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, 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 it would be beneficial to have 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
  • Risk analysis & risk management activities to ISO 14971 and FDA
  • Implementation of various standards and directives relevant to compliance to EU Medical Device Directive 93/42/EC and ISO 13485
  • Comprehensive understanding and Implementation of ISO 13485, FDA 21 CFR Part 820, Canadian ISO 13485 into quality management systems from inception and to upgrade existing systems and knowledge of MDSAP.
  • 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 Senior 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.

Applications must be submitted by Thursday 30th November 2017, for those selected for an initial interview, these are currently planned to be held week commencing the 4th December 2017.

Please note we are currently not accepting applications via agencies.

Job

Regulatory/QMS.

Primary Location

Warwick, United Kingdom.

Schedule

Full-time.

An Exciting Career Opportunity With Advena Limited

Job description

Role Title

Regulatory Associate – Medical Devices

Location

Office Based in Warwick, United Kingdom

Rewards

Competitive salary.

About Us

Advena is essentially two companies; Advena Limited and Advena Medical Limited, both based at our offices in Warwick, UK. Both companies are expanding medical device consultancy business, Advena Limited also has an office in Malta. 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 products.

Summary

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

As 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 would allow you to use your 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, in the capacity of a regulatory associate, 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 and FDA
  • 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 Thursday 30th November 2017, for those selected for an initial interview, these are currently planned to be held week commencing the 4th December 2017.

Please note we are currently not accepting applications via agencies.

Job

Regulatory/QMS.

Primary Location

Warwick, United Kingdom.

Schedule

Full-time.

Reusable Surgical Instruments in EU Regulation 2017/745

A Reusable Surgical Instrument is defined as: “an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.” – 2.3, Chapter I, Annex VIII.

It should be noted that only devices without a connection to an active medical device can be defined in this manner, otherwise they will be given a higher classification. Examples of devices falling into this class include:

  • Scalpels and scalpel handles
  • Reamers
  • Drill bits
  • Saws, that are not intended for connection to an active device
  • Retractors, forceps, excavators, and chisels
  • Sternum retractors for transient use.

Considerations in the Medical Device Regulation

Under the current Medical Device Directive, these devices fall under Class I, with no Notified Body (NB) involvement (unless sold sterile). Similarly, the Medical Device Regulation also classifies these devices as Class I, however will now require Notified Body involvement with respect to the following aspects relevant to the reuse of the device:

  • Cleaning
  • Disinfection
  • Sterilisation
  • Maintenance and functional testing
  • Related instructions for use.

In line with point 7 of Article 52 of the MDR, the manufacturer will be required to:

  • Issue a Declaration of Conformity
  • Establish and maintain the technical documentation in accordance with Annexes II and III
  • Apply the procedures laid out in either Chapter I and III of Annex IX, or in Part A of Annex XI.

Conformity assessment with respect to Annex IX will be based on a Quality Management System and on the assessment of technical documentation, whilst a conformity assessment with respect to Annex XI will be based on product conformity verification.

This situation is very similar to that of Class I devices supplied in a sterile condition, or with a measuring function. It is evident that a vital part of conformity with the Regulation will be to provide detailed procedures for the processes involved in preparing the device for reuse. The manufacturer must also supply information on the validated method of re-sterilisation appropriate to the Member State in which the device is placed on the market.

Furthermore, the manufacturer must provide the end-user with information indicating the limitations of reuse so as to maintain device safety and performance. Such information could include the maximum allowable number of reuses, or guidance on how to recognise the signs of material degradation which could indicate that the device is no longer safe to use. Information on the maximum amount of times the device can be reused will eventually need to be provided to the UDI database. In addition to this, it is also required that any traceability, or safety information present on the device should remain legible after every preparation for reuse.

If you require any assistance on bringing your Reusable Surgical Instruments into conformity with the MDR, please do not hesitate to contact us at info@advenamedical.com.

Intended Use VS Indications For Use

Over the years, the amount of regulatory terminology seems to grow at a constant rate, and so it is no surprise that even the more fundamental terms start getting confused. We have seen many cases in which “Intended Use” and “Indications for Use” have been used interchangeably. Sometimes, “Indications for Use” are not even considered! So why does it matter?

The “intended use” of a device is critical for determining its classification, and is usually defined during the initial regulatory stages. However, the “intended use” is often misunderstood. Its purpose is not to describe what the device is intended to be used for. Instead, it should lay out the claims of what your device is meant to do. This is precisely why the classification will be based on the intended use, that is, on the manufacturer’s claims. It is good practice to keep the intended use statement concise, as long as it details all the fundamental claims appropriately.

On the other hand, the “indications for use” will lay out the conditions in which the user would use the device, that is, the reason or situation for use.

If you have any further questions, please let us know!

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