Quality & Regulatory Associate (Medical Devices)

Location: Manchester, UK (hybrid / flexible – minimum 3 days per week in Manchester)
Reports to: Operations Director (interim)
Role type: Full‑time, permanent
Level: Junior–Mid (not Senior / not Lead)
Works closely with:

·       External QA/RA consultants

·       Engineering ((including software, systems and V&V activities)

·       Operations

·       Manufacturing and supplier partners (as required)

Role Purpose

ScubaTx is seeking a hands‑on Quality & Regulatory Associate to support the execution of our Quality Management System (QMS) and regulatory activities as we progress through ISO 13485 readiness and FDA 510(k) preparation.

This role is primarily executional focused, supporting external QA/RA consultants and internal teams to ensure documentation, design controls and quality processes are implemented accurately and on time. Strategic regulatory decisions and final sign‑off remain with senior leadership and external advisers.

This is an excellent opportunity for someone looking to develop their QA/RA career in a high‑impact med‑tech environment, with exposure to full‑lifecycle quality systems and US/EU regulatory pathways.

Key Responsibilities

1. Quality Management System (QMS) Execution & Coordination

• Support day‑to‑day operation of the ISO 13485‑aligned QMS

• Maintain and update controlled documents, records and templates

• Coordinate document reviews, approvals and version control

• Support adherence to design controls, change control and CAPA processes

• Both independently and, where necessary with guidance, prepare documentation and evidence packs for internal readiness reviews and external audits

• Track actions, gaps and remediation activities arising from audits or reviews

2. Design History File (DHF) & Technical Documentation Support

• Support population and maintenance of the Design History File (DHF)

• Ensure coordination of inputs from relevant teams including: engineering, software and systems teams

• Ensure alignment between:

  • Design inputs and outputs

  • Risk management documentation

  • Verification and validation evidence

• Support traceability between requirements, risks, tests and mitigations

3. Regulatory & Human Factors Interface Support

• Support external QA/RA consultants with preparation of regulatory documentation

• Coordinate inputs for FDA 510(k) and UK/EU technical documentation (as directed)

• Support alignment of human factors / usability activities with:

  • Risk management files

  • Design documentation

  • Labeling and IFU drafts

• Track versions, timelines and dependencies across regulatory workstreams

4. Supplier & Training Documentation Support

• Support compilation and maintenance of:

  • Supplier quality files

  • Supplier approvals and assessments

  • Training plans and training records

• Coordinate with Operations and Engineering to ensure evidence is complete, accurate and current

5. Cross‑Functional Quality Support

• Act as a quality point‑of‑contact for internal teams on documentation and process questions

• Encourage good documentation discipline and quality ways of working

• Escalate quality, regulatory or delivery risks clearly and early

• Support continuous improvement of quality processes as the organisation scales

What This Role Is Not

To set clear expectations, this role:

• Does not own regulatory strategy

• Does not act as Head of QA/RA, PRRC, or Named Person

• Does not carry final audit or submission sign‑off responsibility

• Does not include line‑management responsibility at this stage

These responsibilities remain with senior leadership and external consultants.

As the company scales post‑fundraise, a more senior QA/RA leadership role is expected to be introduced, with this position forming part of the core quality function.

Required Experience & Skills

Essential

• Experience working in Quality Assurance and/or Regulatory Affairs within:

  • Medical devices

  • Diagnostics

  • Regulated healthcare technology

  • With exposure to product development, design controls, or technical documentation

• Hands‑on experience supporting an ISO 13485 QMS

• Familiarity with:

  • Design controls

  • DHF structures

  • Risk management (ISO 14971 awareness)

• Strong documentation writing and reviewing skills in a regulated environment and with excellent attention to detail

• Ability to coordinate work across technical and non‑technical teams

• Confidence working with external consultants and structured regulatory frameworks

Desirable (but not required)

• Exposure to FDA 510(k) submissions (in a supporting role)

• Familiarity with:

  • Human factors / usability documentation

  • Supplier quality documentation

• Understanding of UKCA / CE / MDR technical documentation structure

• Experience in a startup or scale‑up med‑tech environment

Personal Attributes

• Highly organised and delivery‑focused

• Pragmatic, calm and solutions‑oriented

• Comfortable asking questions and escalating issues appropriately

• Collaborative, low‑ego working style

• Motivated to grow into broader QA/RA responsibility over time

Salary & Benefits

Commensurate with experience

We are looking to appoint at a junior–mid level, and the salary will reflect hands‑on experience within regulated medical device or healthcare environments.

In addition to base salary, we offer flexible working arrangements and the opportunity to gain direct experience supporting ISO 13485 readiness and FDA 510(k) preparation in a growing medical‑device company.

Why Join ScubaTx?

• Direct impact on organ preservation and transplantation outcomes

• Significant responsibility early in your career

• Close working relationships with senior leadership and specialist consultants

• Broad exposure across quality systems, design controls and regulatory preparation

• Opportunity to grow with the company as it scales

To apply for this role email us at - info@scubatx.com. Please include “Quality & Regulatory Associate (Medical Devices)” in the subject.