Regulatory Associate – 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 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.
- 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.
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.
Warwick, United Kingdom.