Post Market Surveillance Specialist
We are searching for an ambitions quality assurance / regulatory affairs professional with experience in post market surveillance, vigilance, complaints handling to join an international medical device company. This is the platform to play a lead role in the UK operation and contribute at a time of improvement and investment within the Quality Assurance and Regulatory department.
This is a great opportunity to work in a fast-paced environment and enjoy a role where real career development and progression is on offer; working alongside a Director with a passion and track-record for enhancing people's careers.
Ideally, you will already have worked within the Medical Device industry but candidates from broader areas of healthcare, pharma and pharmacovigilance could also have the skills required.
Post Market Surveillance Responsibilities:
" This position is focused around post market surveillance / PMS, complaint handling and vigilance in its entirety.
" As the Post Market Surveillance Specialist, you will take ownership for coordinating the complaints, adverse events and field corrections for the Northern Europe region.
" You will be working in partnership with the Post Market Surveillance Manager in the identifying, analysing and prioritising issues that have or may result in customer dissatisfaction.
" Creating data analysis tools and reporting and interacting with the sales and distribution departments.
" Ideally, circa 5 years' relevant experience within medical device' regulatory affairs.
" Good working knowledge of regulations, quality systems and guidelines: CE Mark; Medical Device Directive / MDD MDR ; ISO 13485; ISO 14971; 21 CFR 820 US FDA requirements or other industry requirements i.e. pharmaceuticals.
If you are looking for an opportunity to play a lead role in a Quality & Regulatory team within a growing business that provides a flexible approach to your work and career development get in touch with interviews available in early May.
Please send your CV and contact James Powell of TXM Recruit.
("Regulatory affairs" OR "quality assurance" OR vigilance OR pms OR "post market surveillance" OR 93/42 OR mdd)
TXM Recruit is an equal opportunities employer. If you have any specific requirements or require assistance or reasonable adjustments to be made for you during the selection process due to disability or long-term health condition, we will do our best to assist you.