Regulatory Affairs Specialist

6 months ago

Oxford, United Kingdom Adaptix Full time

**Description**:
**Want to be part of a team transforming healthcare?**

We are looking for an experienced
**Regulatory Affairs Specialist **to join us at an exciting time as we transfer our world-leading technology from R&D to manufacture. Working within the Quality and Regulatory team, you will be responsible for ensuring compliance with applicable medical device regulations, guidance, and standards for jurisdictions where Adaptix radiation emitting Class II (FDA) and Class IIb (CE) devices are marketed.

**The Company**

Medical imaging helps patients by enabling early and accurate diagnosis. However, 2D X-rays can be inconclusive as they give a fundamentally limited view of our 3D bodies. 3D images are possible with CT scanners but these are much more expensive, give a high dose of radiation and moving a critically ill patient to a scanner can be labour-intensive and risky.

At Adaptix we are helping make 3D imaging more accessible to the people who need it by producing mobile flat-panel X-ray systems that can be brought to patients giving low-cost, low-dose imaging.

**Key Responsibilities**:
**Main duties and responsibilities**:

- Working with colleagues in the Quality & Regulatory team, and leading on regulatory submissions (e.g. UKCA, CE under MDR, 510k), preparing responses to regulatory authorities’ questions, registrations, and listings globally.
- Writing, analysing and editing technical documents to support country-specific regulatory submissions and compiling submissions in a format consistent with applicable guidance documents
- Working collaboratively across the organisation to manage and communicate the requirements for regulatory submissions
- Assessing and documenting the regulatory impact of product design changes in jurisdictions where the product is licensed. This can include mechanical, electrical and software design, and security features
- Conducting post-market surveillance activities and communication with regulatory authorities
- Providing additional support to the Quality & Regulatory team, for example by participating in design projects as an independent reviewer

**Skills, Knowledge and Expertise**:
**Skills**:

- In-depth knowledge of the EU and US regulatory landscapes
- Knowledge of design and development process principles according to ISO 13485:2016 and 21CFR820 quality system regulations
- Excellent technical writing skills and ability to handle large documentation sets for regulatory submissions
- Understanding of medical device security and cybersecurity requirements
- Excellent organisational and planning skills with ability to manage concurrent projects and adapt to changing priorities.
- Gains the trust of others by providing expert information and advice in a professional and credible manner and inspires others to do the same
- Detail focus with the tenacity to see tasks through to their successful completion
- Ability to communicate technical requirements both verbally and in writing, and build positive internal and external relationships
- Proactive, self-motivated and driven to achieve results
- Comfortable working both independently and collaboratively within a team

**Experience**:

- Managing contracts with CE Authorised representatives
- Proven track record of managing registrations with FDA, MHRA, or European competent authorities
- Experience in hosting / assisting in NB / Regulatory authorities audits
- Active involvement in post market surveillance processes in higher class devices across multiple territories
- Medical X-ray FDA and CE regulatory submissions (desirable)
- FDA's Third party review process (desirable)

This is a permanent full-time role based at our commercial offices in Oxfordshire. Compensation is competitive and commensurate with experience.

If you feel that you would excel in this role we would be delighted to hear from you

**About Adaptix**:
Adaptix is transforming radiology by bringing to market an addressable Flat Panel X-ray Source (FPS) with integrated power supply and controls. Adaptix is a developer of addressable distributed arrays for X-ray generation.

Our patent-protected technology enables fast movement-free 3D imaging at a significantly lower dose than CT. The FPS is designed to allow 3D image formation by means of tomosynthesis using existing generations of Detectors and Workstations, allowing a system price point similar to that of current 2D systems.

Our vision is that our technology will enable 3D X-ray imaging to be cheaper, more widely available and truly portable throughout the world’s clinics and hospitals.

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