Quality & Regulatory Associate (Medical Devices) in Manchester

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)
• 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

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:

Labeling and IFU drafts

Track versions, timelines and dependencies across regulatory workstreams

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

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

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

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

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