This role is a hybrid opportunity working from our Chepstow office 2 days a week fixed as Tuesday and Wednesday and 3 days from home.
Our culture at IQ Endoscopes
VALUES : We work together to achieve shared goals through our values…
PASSIONATE: We show our pride and enthusiasm
INNOVATIVE: We challenge, question and push past the status quo
EMPOWERED: We support our people to explore their own potential
INCLUSIVE: We understand the value of an alternative perspective
TRANSPARENT: We are open to our people, sharing information and knowledge
Equity, Diversity and Inclusion at IQ Endoscopes
At IQ Endoscopes we work hard, but we give ourselves a break. We support each other, but we question and challenge each other’s thinking. We recruit highly skilled professionals and specialists, but we collaborate and listen to each other’s opinions and ideas. It doesn’t matter where you come from, what your background or beliefs are, who you love or how you express yourself. What matters is that you are you, and you can be you within our team. Our inclusive culture has grown organically as a result of focusing on recruiting the right person with the right skills. Nothing else. Plain and simple.
We welcome applications from the neuro enlightened community. Talk to us if you have any ideas about how we can improve our recruitment process. We want to know! hr@iqendoscopes.co.uk.
Your opportunity
IQ Endoscopes is seeking a motivated individual to fulfil the Regulatory Affairs Specialist role which will play a key part in IQ Endoscope’s Regulatory and Quality department. This position will support various regulatory and quality-related processes and will assist in obtaining, maintaining, and supporting regulatory submissions to ensure compliance with industry standards and regulatory requirements.
What we will give you
Hybrid working fixed and 2 days on site Tuesday and Wednesday
25 days annual leave plus bank holidays
2 additional paid ‘Disconnect Days’ per year following probation
2 additional days paid dependents leave & paid compassionate leave per year: entitlement from day 1
Enhanced pension 5% paid by employer & 3% employee
Refer a friend bonus
£100 equipment allowance
Health Shield: Employee health & wellbeing platform encompassing:
o 24/7 EAP service
o A cashback service for both essential and non-essential health and well-being treatments
o GP Anytime: 24/7 access to a phone or chat based GP
o Face to face counselling: referral where required through EAP service
o Access to online health screening, physiotherapy & skin detection
o Employee PERKS & gym discount scheme
Your main responsibilities
Compile and update Technical Documentation for UK and EU submissions for existing and new products.
Review and approve product and process change requests as needed to ensure regulatory compliance.
Support the development and maintenance of clinical evaluation documents in compliance with EU MDR and UK MDR.
Update and maintain Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities.
Review and approve product labelling to ensure regulatory compliance.
Ensure ongoing compliance by keeping regulatory processes, including SOPs and WIs, updated and aligned with current legislations.
Assist in the preparation and submission of 510(k) for the US market.
Support quality function in handling complaints, change control, deviation, and CAPA.
Assist in global registration activities.
Provide regulatory support to internal stakeholders across the business as needed.
What you must have
A degree level qualification or equivalent in a relevant scientific discipline.
Minimum of 2 years of experience in similar role within medical device regulatory affairs.
Working knowledge of MDR 2017/745, UK MDR and US FDA 21 CFR 820.
Strong knowledge of Quality Management Systems (e.g. ISO 13485).
Experience in compiling and submitting Technical Documentation.