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Advena Add More Experience to Their Team

This month we welcome Richard Bassett to our team at Advena Limited., as our newest Senior Regulatory Consultant and QMS expert.

Some of you will already know Richard as he is joining us from a well-known major UK Notified Body where he has been a Client Manager and Lead Auditor. This has included working as a Lead Assessor for EN ISO 13485 and ISO 9001 systems covering all medical devices including IVD devices. Richard is a certified Auditor for almost all aspects of device CE marking, CMDCAS and overseas GMP requirements and has been closely involved in managing Notified Body audit teams. Richard is also an MDSAP lead auditor.

Specifically, Richard has been involved in management teams responsible for Quality Management Systems and Technical Files which included IVD Devices, Pregnancy Test Kits, Contact Lens Solutions, Eye Drops and Ear Drops plus the management and execution of associated supplier and internal audits.

This experience has involved working with risk management and the preparation of technical documentation including the classification conversion of cosmetic products to medical devices – an important issue under the new MDR and IVDR regulations.

Richard’s qualifications include an MSc in Structural Molecular Biology with a dissertation on the Structure and Function of Antibodies (specific to IVD research) and he is now completing a dissertation on Medical Device Regulation. These higher level qualifications complement an earlier BSc in Biomedical Science where study topics included biochemistry, medical microbiology, biotechnology, genetics, and immunology.

Richard’s background is specifically of note when considering the new classification systems for IVD devices in the EU.

Undoubtedly Richard has a wealth of experience to offer our existing and prospective clients alike and we welcome him to our expanding company. If like many of our clients you are looking for excellent experienced regulatory support please email Advena for a solution to meet your regulatory needs, please email: 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.

Fantastic Employment Opportunity at Advena

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 Friday 9th September 2017, for those selected for an initial interview, these are currently planned to be held week commencing the 25th September 2017.

Please note we are currently not accepting applications via agencies.

Job

Regulatory/QMS.

Primary Location

Warwick, United Kingdom.

Schedule

Full-time.

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