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;
QMS & Medical Device Regulatory Consultant.
Office Based in Warwick, United Kingdom.
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.
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.
- 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.
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.
Warwick, United Kingdom.