Senior Regulatory Consultant – Medical Devices
Office Based in Warwick, United Kingdom
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.
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.
- 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.
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.
Warwick, United Kingdom.