Join to apply for the Regulatory Specialist role at Medichecks
Join to apply for the Regulatory Specialist role at Medichecks
Hours: Full Time - 12 Month Fixed Term Contract
Location:Hybrid* (Head office Nottingham)
Medichecks launched the UKs first direct-to-consumer blood testing company in the UK and created a market where there was none. As well as the continued growth of our B2C business we now see considerable opportunity to grow in the B2B and B2B2C space through our technology platform, Plasma.
Our vision is to be part of everyone’s journey to better health. At Medichecks we’re building a healthcare platform for the future. We’re a team of medics, designers, engineers and communicators who are intent on bringing our vision to life. We’d like to hear from people who want to use their skills and knowledge to improve peoples’ lives and help us create real change in the way that blood testing and insights can be delivered.
Purpose of this role
The role will be part of a growing Quality and Regulatory team working alongside a motivated and experienced QA/RA team. You will be responsible for writing compliant technical file documentation and providing regulatory support in maintaining and updating Medical Device Technical files compliant with MDR/IVDR. In addition, you will also lead in delivering the Post Market Surveillance strategy and reports and be confident in managing multiple regulatory priorities. The individual has to gain department-level influence by sharing regulatory expertise to demonstrate compliance with changing regulations, identifying, preparing and collecting data needed to support certifications and maintain compliance with our products. This role will be reporting directly into the Senior Quality and Regulatory Manager.
Role and responsibilities
* Responsible for independently leading the implementation of the CE and UKCA marking for the growing portfolio of Medichecks medical devices and IVDs. This will involve writing technical file documents from scratch using the existing framework.
* Responsible for leading the successful implementation of UDI (Unique Device Identifier) for our CE and UKCA marked devices independently and ensuring all technical files have been updated accordingly.
* Responsible for ensuring existing technical files are maintained and up to date in line with evolving regulatory requirements.
* Responsible for independently writing UKCA and CE compliant technical files and DHF documents, ensuring compliance with industry standards to ISO 13485, ISO 14971 and ISO 15223 requirements
* Assess device changes and impact on Technical Files, ensuring Medichecks Change Control process is followed for technical file revisions.
* Subject matter expert for the review and development of product packaging, product labelling, product claims and promotional items to ensure all applicable regulatory requirements have been met i.e. ISO 15223, IVDR, ISO 13485 requirements.
* Act as a subject matter expert for changes to device labelling and effectively communicate guidance with teams
* Support key development projects within the team to meet strategic business objectives.
* Responsible for conducting post-market surveillance and vigilance activities. Reporting on findings periodically as defined by Medichecks’ QMS.
* Negotiate and interact with regulatory authorities (where required) during the development and review process for CE marking to ensure submission approval. Support handling CAPAs to implement corrective and preventative actions.
* Provide regulatory input to support the resolution of manufacturing issues with fulfilmentand ensure these actions are documented using the QMS framework.
* Monitor the impact of regulatory changes in the industry and share the monthly report with QA/RA Team.
* Provide regulatory input with New Product Development.
* Support internal and third-party audits when needed.
* Assist in the day-to-day activities of the QA&RA team when required.
* Participate in team building exercises as part of the QA Team and wider Clinical Department at Medichecks.
Skills and Experience
* Must be comfortable with attending the office at a minimum, once a month, and when required to complete work-related tasks which require you to be present in person, such as audit days, product signoffs, internal workshop.
* The ability to assimilate information from different stakeholders and distill this information to clear tactical summaries and proposals.
* Ability to communicate effectively and efficiently both verbally and in written form with cross-functional stakeholders.
* Responsible for acting as a voice for the team to communicate Regulatory guidance and requirements, to assist in educating key stakeholders.
* Act as a voice for the team to communicate Regulatory guidance and requirements.
* A self-starter who is not afraid to get stuck in and give things a go independently.
* A proven ability to plan, coordinate and manage multi-disciplinary projects, i.e. CE marking devices alongside day-to-day RA tasks.
* Comfortable in saying ‘no’ to senior stakeholders if required from a Regulatory perspective and articulating the rationale in a considered and evidence-based way, taking their audience into account.
* Ability to provide presentations as subject matter expert to educate stakeholders or the wider business on regulatory topics.
* Experience with writing technical files, design history file documents and knowledge of the STED format.
* Familiar with using the GS1 and Eudamed portals.
* Proactively carry out self-learning activities to keep up with evolving regulatory requirements.
How we work
We have adopted a flexible hybrid approach to working in both the office and at home, having seen the benefits of both for everyone during the last year.You will predominantly work from home, but sometimes we will get together to collaborate, or for 121s.
We offer flexible working around our core business hours and trust you to work enough hours to do your job well, at times that suit you and your team.
Reasonable Adjustments
We are committed to offering reasonable adjustments to support you to succeed in our interview and assessment process. So, if we can do anything to make our process more accessible for you, please let us know by contacting a member of our People Team by email to people@medichecks.com .
Make A Difference
We all share one dream to make blood testing simple so that we can benefit everyone’s health.
We’re not about being overcomplicated; we want to do the right thing (even when it’s not easy) and positively impact people’s health.
Respect Everyone
We’re inclusive, and we treat all people with kindness and respect.
We value everyone’s opinion and go above and beyond to support our colleagues, clients, customers - and anyone else we meet along the way.
We’re medically led and make evidence-based decisions to ensure we deliver quality services and products.
We’re an ambitious team. We encourage growth and being curious, and we will never (ever) stop learning.
Medichecks people, perks and culture
We are committed to making Medichecks a great place to work and have shaped our people strategy around our colleagues’ feedback and we are continuously reviewing this.As well as a competitive salary and the chance to make a real impact in an organisation, here's a taste of some of the things weoffer.
·25 days of glorious holidays, plus all of the bank holidays
·The option to buy and sell holiday
·Hybrid working- working anywhere from the UK
·Company pension – including salary sacrifice options
·Flexi lunch breaks – grab lunch with a friend or hit the gym
·Enhanced maternity and paternity leave, as part of our family friendly policies
·Enhanced paid sickness leave
·Free and discounted Medichecks blood tests for you and your family and friends
·Free access to an online GP service
·Free eye tests and flu jabs
·Access to discounts and freebies through our reward platform
·2 days of paid leave to give some of your time to a charity or community of your choice
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Job function
Legal
* Industries
Wellness and Fitness Services
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