01
Quality
Engineers and leaders who build and run device quality systems.
- Quality Engineer
- Principal Quality Engineer
- Director of Quality
Medical Devices Engineering Life Sciences
Recruitment for the people who build medical devices.
We are a family-run recruitment consultancy for medical devices, engineering and life sciences, with 30+ years of combined industry experience.
What we do
We recruit for medical device companies, from start-ups and scale-ups to global manufacturers. We fill quality, regulatory, clinical, engineering, operations, commercial and executive roles, mostly from mid-senior level up, in the UK, Ireland, mainland Europe and the US.
Device areas include
- Diagnostics (IVD)
- Drug delivery
- Wound care
- Healthcare technology manufacturing
Recruitment
From quality engineers to chief executives.
Roles from engineer to board level, for clients from start-ups and scale-ups to global manufacturers.
02
Regulatory affairs
QA/RA specialists who keep devices compliant and get submissions through.
- QA/RA Specialist
- Regulatory Affairs Specialist
03
Clinical
People who run clinical studies and lead clinical strategy.
- Clinical Study Manager
- Chief Medical Officer
04
R&D and NPI engineering
Engineers who design new devices and bring them into production.
- R&D Engineer
- NPI Engineer
05
Manufacturing, validation and operations
The people who industrialise a device, validate the process and keep production running.
- Industrialisation
- GxP and validation
- OT
- Supply chain
- Head of Operations
06
Commercial
Roles that take a device to market and plan where it goes next.
- Commercial operations
- Strategy and planning
- Product management
07
Executive
Leadership appointments, which we can run as a confidential search.
- CEO
- COO-track
- CMO
- Engineer and specialist
- Senior and principal
- Manager and lead
- Head and director
- Chief executive and C-suite
Engineer and specialist roles too, for example Quality Engineer and QA/RA Specialist.
- Quality Engineer
- Clinical Study Manager
- Principal Quality Engineer
- QA/RA Specialist
- NPI Engineer
- Head of Operations
- Director of Quality
- Product Manager
- Chief Medical Officer
- R&D Engineer
- CEO
Device lifecycle
Who a device programme needs, stage by stage.
From first concept to post-market, the specialists a programme needs change as the device moves on. Quality and leadership run through all of it.
How device programmes are typically staffed
| Role family | Concept and feasibility | Design and development | Verification and validation | Regulatory submission | Design transfer and manufacturing | Launch and commercial | Post-market |
|---|---|---|---|---|---|---|---|
| R&D and systems engineering | Needed | Needed | |||||
| Software (IEC 62304) | Needed | ||||||
| Human factors | Needed | ||||||
| Test and design quality engineering | Needed | ||||||
| Regulatory affairs | Needed | Needed | |||||
| Clinical evaluation | Needed | ||||||
| NPI, process and validation engineering | Needed | ||||||
| Supply chain | Needed | ||||||
| Commercial operations | Needed | ||||||
| Product management | Needed | ||||||
| PMS, complaints, CAPA and vigilance | Needed | ||||||
| Quality (ISO 13485 QMS) | Needed | Needed | Needed | Needed | Needed | Needed | Needed |
| Leadership | Needed | Needed | Needed | Needed | Needed | Needed | Needed |
-
01
Concept and feasibility
Defining the clinical need and intended use, and testing whether the device can be built.
- R&D and systems engineering
- Regulatory affairs
-
02
Design and development
Turning user needs and requirements into hardware, software and a usable interface.
- R&D and systems engineering
- Software (IEC 62304)
- Human factors
-
03
Verification and validation
Proving the design meets its requirements and works for the people who will use it.
- Test and design quality engineering
-
04
Regulatory submission
Assembling the technical documentation and clinical evidence for approval in each market.
- Regulatory affairs
- Clinical evaluation
-
05
Design transfer and manufacturing
Moving the design into validated, repeatable production and a working supply chain.
- NPI, process and validation engineering
- Supply chain
-
06
Launch and commercial
Taking the device to market and supporting the people who buy and use it.
- Commercial operations
- Product management
-
07
Post-market
Monitoring the device in use, handling complaints and acting on what is found.
- PMS, complaints, CAPA and vigilance
Throughout: quality (ISO 13485 QMS) and leadership.
Regulation As at October 2026
Why quality and regulatory people are in demand.
New rules and transition deadlines in Great Britain, the EU and the US all fall to device quality and regulatory teams.
Context, not regulatory advice.
-
GB
1Post-market surveillance requirements in force
New rules for how manufacturers monitor devices once they are on the market in Great Britain.
-
EU
2Commission proposes simplifying MDR and IVDR
The European Commission proposed changes to both regulations. The proposal is still going through the legislative process.
-
US
3FDA's Quality Management System Regulation takes effect
The QMSR brings ISO 13485:2016 into 21 CFR 820 by reference.
-
EU
4MDR transition ends for class III custom-made implantable devices
From this date, these devices need MDR certification to be placed on the EU market.
-
Now
October 2026. Everything below is still to come.
-
EU
5MDR transition ends for class III and class IIb implantable devices
The next group of legacy devices that must move to MDR certification.
-
GB
6GB stops accepting CE marks under the old directives
CE-marked devices certified under the MDD or AIMDD are no longer accepted in Great Britain.
-
EU
7MDR transition ends for other class IIb, class IIa, and sterile or measuring class I devices
The last of the MDR transition dates set by Regulation (EU) 2023/607.
-
GB
8GB stops accepting CE marks under EU MDR and IVDR
This is the date as currently legislated. The MHRA consulted in February 2026 on recognising these CE marks indefinitely; the outcome is pending.
Sources
- U.S. Food and Drug Administration, Quality Management System Regulation (QMSR) page, fda.gov
- Regulation (EU) 2023/607, amending Regulation (EU) 2017/745 on transitional provisions
- GOV.UK, "Regulating medical devices in the UK"
- European Commission, COM(2025) 1023
Summarised for context as at October 2026. This is not regulatory advice.
How we work
Permanent, contract or a confidential search.
Every search is hands-on and built around the role. We know the technical side of the jobs we fill, and we look after candidates as carefully as we look after clients.
Permanent
Full-time hires into your team, from experienced engineers to directors. We stay involved through the offer, notice period and start date.
Contract and interim
Specialists for a set period: to cover a gap, run a project or see a submission through. UK contracts, including some outside IR35.
Confidential and executive search
Senior and board-level appointments handled discreetly, for roles that cannot be advertised openly.
How a search runs
- 01
Brief
We agree the role, the skills it needs, the team it joins and the package.
- 02
Search
We search the market and approach suitable people directly.
- 03
Shortlist
You get a short list of screened candidates, with notes on each.
- 04
Interviews
We arrange the interviews and pass on feedback both ways.
- 05
Offer
We manage the offer and the negotiation with both sides.
- 06
Start and follow-up
We keep in touch through notice and after the start date.
Coverage
Recruiting across the UK, Europe and the US.
We recruit for roles in the UK and Ireland, mainland Europe and the United States. Call the UK and Europe line or the US line, whichever suits your time zone.
- UKand Ireland
- Central EuropeMainland Europe
- US EasternUnited States
- US PacificUnited States
UK and Europe+44 (0)113 517 9740
Team
A family-run firm.
John and Olivia MacDonald founded Maclivaro in 2024 and are its directors.
30+
years of combined industry experience
John MacDonald
Director and Co-founder
In recruitment since 2008. John set up and led engineering and contract recruitment divisions in the UK, Europe and the Middle East, then spent two years as a director at a specialist life-sciences recruiter before co-founding Maclivaro in 2024.
LinkedIn profile for John MacDonald (opens in a new tab)
OM
Olivia MacDonald
Director and Co-founder
A medical device quality and regulatory recruitment specialist. Olivia previously led a medtech QA/RA recruitment desk and has recruited across the UK, Europe, the Middle East and the US.
LinkedIn profile for Olivia MacDonald (opens in a new tab)Contact
Tell us about the role, or the role you want.
Use the form, or email and call us directly. Current roles are posted on our LinkedIn page.
- Emailjohn@maclivaro.com
- Phone, UK and Europe+44 (0)113 517 9740
- Phone, US+1 206 821 3766
- LinkedInMaclivaro Limited (opens in a new tab)