Regulatory Specialist

**The Role: Regulatory Specialist**

**The Team: Trust**

**Hiring Manager: Sunali Purba - Head of Quality and Regulatory Affairs**

**Hours: Full Time, Permanent**

**Location: Hybrid* (Head office Nottingham)**

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.

**Purpose of this role**

Medichecks has been growing fast in the consumer blood testing market. As well as the continued growth of our D2C business we now see considerable opportunity to grow in the B2B and B2B2C space through our technology platform.

The Regulatory Specialist 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. You will 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.

**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
- 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 fulfilment and 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 required
- Assist in the day-to-day activities of the QA&RA team when needed.
- Participate in team building exercises as part of the QA Team and wider Clinical Department at Medichecks

**Skills and Experience**
- Assimilate information from different stakeholders and distil this information to clear tactical summaries and proposals
- Communicate effectively and efficiently both verbally and in written form with cross-functional 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
- 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
- Strong 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 at our Nottinghamshire office.

We offer flexible worki