Regulatory Affairs Specialist in Chepstow

Title Regulatory Affairs Specialist

Hours 37.5 per week / full time

Reports to Head of Regulatory & Clinical Affairs

Reports in None

Location Office, in line with hybrid policy

Start date April 2025 TBA

Culture of IQ Endoscopes
We have a product with the capacity to genuinely change lives for the better and bring huge benefits to the medical device industry and industry professionals, and we want our new colleagues to feel as passionate about our mission as we are. At IQ Endoscopes, culture is incredibly important to us and we recruit colleagues who fit that culture. This isn’t just a job to us, it’s a passion.

We want you to be a part of our vision and to find your purpose within our organisation.

PURPOSE: To create pioneering endoscopy technologies for the early diagnosis of diseases, helping people live longer & better

VISION: A world where everyone has easy access to safe, sterile endoscopy

MISSION: Design and deploy high quality sustainable single use endoscopes

STRATEGY: To enter the single use endoscopy market as soon as possible with a product range that is clinically and commercially credible, will be adapted to meet future market demands and sets the benchmark for carbon neutral responsibilities

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 others’ 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 are a progressive organization set to disrupt the medical device industry with our innovative and pioneering design – we want diversity to remain progressive, we want equity to breathe our values. We are inclusive because inclusivity is how we will achieve our vision.

Talk to us if you have any ideas about how we can improve our recruitment process. We want to know.

We welcome applications from the neuro enlightened community. If you need us to run our recruitment process in a different way to get the best from your application, contact the HR Manager hr@iqendoscopes.co.uk.

Job purpose
The Regulatory Affairs Specialist role exists to 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.

Key responsibilities
The main responsibilities and activities for this post holder include:

· 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.

· Work inclusively and with equity as part of your natural daily operations to ensure our diversity keeps us progressive in terms of our ways of thinking and collaborating.

· Work to and comply with the principles of the GDPR and our company approach to protecting data and sensitive information.

· Work to and comply with all regulations, standards and accreditations relevant to our business operations and our industry. This applies now and as we evolve to gain further accreditations. For example ISO 13485, 14001, UK and EU MDR Regulations and CFR 820 Code of Federal Regulations.

Key responsibilities are intended to describe the general nature and level of work relating to a specific job role or function area being performed by people assigned to this job. They are not an exhaustive list and all employees are expected to be flexible with the responsibilities they take on, relevant to their job role, but not defined within their job description.

Person specification
Experience and qualifications
Essential

· 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.

Desirable
· Knowledge of other key markets, such as Australia, Canada and Japan.

· Working knowledge of IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-6 standards.

· Experience of internal auditing and auditing critical suppliers / sub-contractors.

Competencies and personality
· Excellent attention to detail enabling strong report writing and Technical Documentation.

· Knowledge of working with electronic document management systems.

· Use of software such as Microsoft Office, including Outlook, Word and Excel, as well as Adobe.

· Interpersonal communication.

· Work well in collaborative, fast moving and adaptive environment.

· Self driven able to manage and create own workload and meet deadlines effectively.

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