QA/RA Consultant
On site
Banbury, United Kingdom
Full Time
27-11-2024
Job Specifications
About IMed
IMed Consultancy’s journey from single consultant company to a thriving and growing business is rooted in its belief that fostering relationships and delivering consulting excellence are fundamental to success. We value collaboration and agility, with a strong focus on delivering proactive, expert guidance and support to surpass client expectations.
This has never been more important time for Medical Devices and IVDs, as new technologies are developed and existing technologies optimised to improve health outcomes and support clinicians in providing better patient care.
IMed Consultancy help companies innovate and develop their products safely and legally, to enable the next generation of health technologies. We support companies from startups and spinouts through to multinationals to achieve their goals, working as a trusted partner alongside client teams, and taking the lead on difficult and complex work activities.
We are thrilled to be offering an opportunity for a new Regulatory Consultant to join the team with experience focussed in the areas of either IVD, Software, or Electronic (active) medical devices. We are looking for candidates with experience of either design and development, regulatory certification and/or post market regulatory compliance with a scientific background or experience.
Responsibilities
As a consultant, you will:
· lead and support projects and work directly with clients on their cutting edge products and technologies.
· Help to bring these solutions to global markets.
· Help users and patients around the globe to access the treatments they need.
· Be at the centre of assisting companies around the globe to access the markets of their choice.
· Keep up to date with the ever-changing Medical Device and IVD regulations and educate stakeholders.
You will work with the wider IMed team, so you will be connected as part of our growing business.
The role is a remote position for persons resident in the UK, with a right to work in the UK. The role will require travel as and when required to head office (Oxfordshire), company events and clients sites in the UK and occasionally abroad.
Core Competencies
· Confident and proactive
· Organising and planning skills
· Strong communicator – multi level
· High level of accountability
· Responsible for quality and accuracy of work
· Interpretation of regulatory requirements
· Ability to develop an understanding of technical functions and operation of products, and their clinical context of use
Requirements
· 3+ years’ experience within medical devices or IVDs through positions in industry, consultancy or regulatory agencies (MHRA, Notified Body etc).
Have a Bachelor’s degree (or higher) in a scientific or technical discipline relevant to medical device manufacture and use, or equivalent industry experience.
Specific experience and knowledge of at least one of the following areas is required;
- In Vitro Diagnostic medical devices which have required regulator approval
- Software as a medical device and/ or digital health software standards such as IEC 62304 and cybersecurity.
- Experience with medical device electronic hardware and IEC 60601 series of standards.
Experience of UK and EU regulatory affairs is required. Strong experience within medical device design and engineering roles with exposure to risk management and design control requirements will be alternatively considered.
Global regulatory affairs experience such as submissions of 510(k), De Novo, TGA, etc. would be an advantage.
Knowledge of ISO 13485:2016. Experience in process implementation and giving training would be an advantage.
To be successful in this role, you will
· Have strong interpersonal communication skills.
· Have drive and energy to succeed.
· Be self-reflective and always look for new solutions.
· Be open to change and have a motivation to grow.
· Have strong time and priority management skills.
· Genuine interest in regulations and client businesses
· Be proactive and a team player
About the Company
We are a medical device regulatory and quality consulting team working with people and their companies to navigate the minefield of todays global medical device regulations to ultimately achieve compliance and success. If you are a start-up company looking for some initial advice through to one of the big boys needing resource for a specific project or training for your team we can help. More importantly we want to help because we love what we do. Working with a team of industry experts as well as our core team we work h... Know more
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