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 Referrals increase your chances of interviewing at Medichecks by 2x Get notified about new Regulatory Specialist jobs in Bingham, England, United Kingdom . 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Contact Details:
Medichecks Recruitment Team
people@medichecks.com
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Specialist in Bingham
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Medichecks looking for candidates who are engaged and informed.
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Medichecks. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Medichecks
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Medichecks’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
