This role is responsible for the delivery of the company's development regulatory roadmap.
About the Company
We are an innovative medical devices manufacturer of advanced wound care products, including combination products, from gelling fibres and fabrics.
We deliver innovative, cost effective and quality products and solutions for the advanced wound care industry helping to improve patient care and wellbeing.
They are looking for an individual that is hard working and self-motivated to assist with all things regulatory.
A long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business.
Responsibilities will include: Provide technical support to the business, suppliers and customers on all matters relating to the safety, legality and quality of the products purchased and sold.
This person will also be responsible to build, implement and maintain regulatory compliance processes including, regulatory evaluation of changes and non-conformances, post-market surveillance, vigilance and associated reporting, regulatory and standard watch.
The roles are responsible for building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the appropriate regulatory authorities worldwide.
Stem Recruitment have a couple of opportunities for experienced RA & Senior RA's based near Edinburgh for a medical device company.
A Regulatory Specialist is urgently required or the responsibility of providing global regulatory and scientific support for new and existing products, raw materials and processes.
Here's a sneak peek into what your role will entail
Technical documentation: You will be responsible for maintaining and updating technical documentation, ensuring compliance with regulations such as MDD to MDR (Medical Device Regulation).
General
We are looking to hire a Regulatory Specialist permanently for a Medical Device manufacturer taking full ownership for their biocide product range.
If you've been looking for a company allowing you to work remotely, this is it.