Getting started guide · Edition 1
Free for candidatesStart strong in European MedTech.
The Vigilo guide for Regulatory Affairs, Quality and Clinical professionals. Set up in ten minutes, read regulatory news with confidence and assess roles like an insider.
10 min
to set up Vigilo so relevant roles and updates come to you
5
relevant dates to tell apart in any EU regulation
7
signals to read in any MedTech job advert
01 · Welcome
Your field moves fast. This guide keeps you ahead.
Regulatory Affairs, Quality and Clinical work in European MedTech sits where EU law, constant guidance updates and a cross-border hiring market meet. Here are the essentials in one place.
What you will be able to do
01
Set up
Get the right roles and updates delivered, without checking job sites every day.
02
Decode
Tell a proposal from an obligation, and a publication date from an application date.
03
Move
See where you could go next, read adverts like an insider and apply with evidence.
Choose your path
Set up alerts and matches, then sharpen how you read adverts and apply.
Learn to read regulatory news, then explore the career map and the glossary.
Ten-minute set-up, then keep the sources and glossary to hand.
Why you can rely on Vigilo
Primary sources first
Every regulatory item links to the regulator, the legal text or the original publisher.
Always up to date
Sources checked every weekday. Roles re-checked the morning we share them.
Close to the industry
In direct contact with companies and industry organisations across Europe.
Specialists only
Only Regulatory Affairs, Quality and Clinical in MedTech. Free for candidates.
Your move
Start with your first ten minutes and complete the set-up now. It takes less than ten minutes.
02 · Your first ten minutes
Set up once. Then the roles come to you.
Get the Tuesday briefing
1 minOne email a week: selected regulatory developments, each with its source and what to check, then verified open roles. Already subscribed? Tick it off.
Create your free account
2 minSign up on vigilomedtech.com with an email link, a password, Google or LinkedIn. Your account lets you save roles and see your Job matches.
Complete your profile
3 minAdd your function, experience and preferences. Vigilo uses your profile to rank live roles on your personal Job matches page. Tick “Email me jobs that match my profile” for a weekly email of up to ten matches. No new matches that week means no email.
Set a job alert
2 minChoose your function, location and remote preference. You get a weekly digest, only when new roles match. Confirm from the email you receive. Change or stop it from any digest.
Follow Vigilo on LinkedIn
1 minShort carousels from Monday to Thursday: open roles, the number of the week, a scenario and a mini tutorial.
linkedin.com/company/vigilo-medtech-jobs
Job alerts or job matches? Use both: they catch different roles
| Job alerts or job matches? Use both: they catch different roles | Job alert | Job matches |
|---|---|---|
| Based on | The filters you choose: function, location, remote | Your profile |
| You receive | A weekly digest | A weekly email with up to ten roles |
| Sent only when | New roles match your filters | There are new matches for you |
| Best for | A precise search you already know | Roles you would not think to search for |
| Switch on | Step 4, then confirm by email | Step 3, then tick the box |
Your move
When your first Tuesday briefing arrives, move it to your main inbox and add the sender to your contacts.
03 · Your week with Vigilo
A fixed rhythm. One format a day. Each one does one job.
Mon
09:00 · LinkedIn
Open roles
Up to five verified roles. If fewer meet the bar, we post fewer.
Tue
09:00 · LinkedIn
Number of the week
One figure with its unit, geography, year and source.
Wed
09:00 · LinkedIn
Story or scenario
A documented public case, or a scenario clearly labelled as illustrative.
Thu
09:00 · LinkedIn
Mini tutorial
One narrow task in three to five steps, with jurisdiction and references.
The Tuesday briefing
Developments, what to check and verified roles. Built to read in minutes.
Tue · 09:30 · Email
Your job alert digest and your Job matches email, only when there is something new for you.
What Vigilo does
A direct route to the right roles
- Lists Regulatory Affairs, Quality and Clinical roles in MedTech, IVD and medical software across Europe.
- Sends you to the original listing to apply, usually on the employer’s own site.
- Explains what changed in regulation, for whom, and what to check.
What “verified” means for the roles we share on Monday and Tuesday
Live
Checked on the original listing the morning we publish.
Direct
Apply opens the original listing, never a copy.
In scope
Regulatory Affairs, Quality or Clinical, in MedTech, IVD or medical software.
Labelled
Paid placements are always marked as such.
Your move
Pick the one format most useful for your job this month and read it every week. Consistency beats volume.
04 · Read regulatory news like a pro
Know which date you are looking at.
Tool 1 · The life of an EU regulation, with the MDR as example
Proposal
2012
The Commission proposes a text. Nothing applies yet.
Adoption
April 2017
Parliament and Council agree the final text.
Publication
5 May 2017
The text appears in the Official Journal.
Entry into force
25 May 2017
The law exists; obligations may still be deferred.
Application
26 May 2021*
The obligations actually apply.
* After a one-year postponement. Four years separate entry into force from application: quoting the wrong one changes the story.
Tool 2 · Legal weight, from binding to claim
Regulations and national law
Binding.
Implementing and delegated acts
Binding, and more detailed than the regulation itself.
Harmonised standards
Voluntary; presumption of conformity.
MDCG guidance
Not legally binding, widely followed.
Proposals
And consultations. Not law yet.
Company claims
Check independently.
Anatomy of a Vigilo update
- 1
EU: what changed, in plain words.
- 2
Key date: named as publication, entry into force or application.
- 3
Who it affects: role and economic operator.
- 4
What to check: one practical next step.
- 5
Source: link to the primary page.
Five questions to ask of any regulatory headline
Where?
EU-wide, one member state, or outside the EU?
How binding?
Law, guidance, proposal or claim?
Which date?
Publication, entry into force or application?
Who?
Manufacturer, importer, representative, notified body?
Says who?
Can you open the primary source?
Worked example · “EU extends MDR deadlines”, March 2023
Where?
EU-wide, and the EEA
How binding?
Law: an amending Regulation
Which date?
In force on publication, 20 March 2023
Who?
Manufacturers of certain legacy devices, under conditions
Says who?
EUR-Lex: Regulation (EU) 2023/607
Your move
Before you forward the next regulatory headline to your team, answer the five questions above in one line each.
05 · The career map
Where you are, where you could go. Three families, many bridges.
Typical titles and standards in each family. Titles vary by company size and country, so read the responsibilities, not just the title.
Regulatory Affairs
Gets devices onto the market and keeps them there: strategy, technical documentation, submissions, authority contact.
- SeniorHead or Director of RA
- LeadRA Manager · PRRC
- MidSenior RA Specialist
- EntryRA Associate or Specialist
Know your way around
MDR · IVDR · MDCG guidance · EUDAMED · GSPR · UDI
Quality
Builds and runs the quality management system: audits, CAPA, complaints, suppliers, risk and design controls.
- SeniorHead or VP of Quality
- LeadQMS or Quality Manager
- MidSupplier Quality · CAPA lead
- EntryQuality Engineer
Know your way around
ISO 13485 · ISO 14971 · IEC 62304 · IEC 62366-1 · ISO 19011
Clinical
Generates and evaluates clinical evidence: investigations, clinical evaluation, performance studies, follow-up.
- SeniorHead of Clinical Affairs
- LeadClinical Affairs Manager
- MidSenior CRA · Clinical Evaluation
- EntryCRA · Clinical Specialist
Know your way around
ISO 14155 · ISO 20916 (IVD) · CER · PMCF · SSCP
Bridges: hybrid roles where two families meet
Post-market surveillance
Quality data meets clinical and regulatory reporting: PMS plans, PSURs, vigilance.
Clinical evaluation
Clinical evidence written for RA and regulatory review.
Software and AI devices
RA and Quality with IEC 62304 and cybersecurity.
Notified bodies
Reviewer and auditor roles that value industry experience.
Skills that travel across all three families
- Risk management thinking
- Clear technical writing
- Audit and inspection readiness
- Reading legal text precisely
- Working across functions
- Data and evidence literacy
A role to know: the PRRC
Article 15 of the MDR and of the IVDR requires manufacturers to have a Person Responsible for Regulatory Compliance; micro and small firms may rely on an external one. The route in: a relevant degree plus one year in regulatory affairs or quality management for devices, or four years’ experience in those fields.
Your move
Mark where you are and the next step you want. Then set a job alert for that title, not your current one.
06 · Decode a MedTech job advert
Read between the lines. Every line of an advert tells you something.
Illustrative example · not a real vacancy
Regulatory Affairs Specialist
Device manufacturer · EU-based · Hybrid
Your role
- 1Maintain technical documentation for Class IIb devices under the MDR
- 2Prepare notified body submissions and answer deficiency questions
- 3Manage EUDAMED and UDI registrations
- 4Act as deputy PRRC
Your profile
- 53+ years in RA for medical devices
- 6Working knowledge of ISO 13485 and ISO 14971
- 7Fluent English; a second EU language is an advantage
- 1
Class and regulation
Higher classes mean deeper documentation and more notified body contact. Match it to the classes you have worked on.
- 2
Notified body contact
Have one concrete example ready: a review you led or a deficiency you closed.
- 3
EUDAMED and UDI
Data-heavy, deadline-driven work. Ask how far their registrations have progressed.
- 4
Deputy PRRC
Check you meet the Article 15 route. It is a step towards the PRRC role itself.
- 5
Years of experience
Often a guide, not a wall. Strong, relevant evidence can outweigh a missing year.
- 6
Named standards
Mirror them in your CV with what you did, not just the number.
- 7
Language
“An advantage” is not “required”. Be honest about your level.
Not in the advert, so ask
- Salary range and on-site days
- Team size and who you report to
- Which notified body they work with
In EU countries, the Pay Transparency Directive (EU) 2023/970 gives applicants a right to pay information before the interview, once transposed into national law.
Same title, different job: who is hiring changes the work
| Manufacturer | Consultancy | Notified body | Start-up | Representative or importer |
|---|---|---|---|---|
Manufacturer Owns the technical documentation. Depth on one portfolio over time. | Consultancy Many clients and devices. Breadth, pace and deadlines set by others. | Notified body Reviews other companies’ files and audits. Strict independence rules. | Start-up Often the first RA or Quality hire. You build the systems. | Representative or importer EU duties on behalf of the non-EU manufacturer: authorised representative, importer, distributor. |
Green flags worth a question
- Named regulation, device class and target markets
- A clear reporting line and team size
- A salary range and a realistic list of must-haves
- A long list of standards with no context
- RA, Quality, Clinical and PRRC duties in one junior role
- No word on which products or markets you will cover
Your move
Take the last role you saved and annotate it with these seven signals before deciding whether to apply.
07 · Apply and interview
Apply with evidence. Interview with questions.
From reading to applying.
Before you click apply
Match the framework
Same regulation, device type and class as your experience?
Use their words
Reuse the advert’s standards and terms where they are true for you.
Check the basics
Location, on-site days, language, travel and contract type.
Show evidence
Audits hosted, files remediated, submissions led, studies monitored.
Know where you apply
On Vigilo, Apply opens the original listing.
Save and compare
Save the role in your account and decide with a clear head.
Write evidence, not duties: a four-part line for your CV
Action
What you did
Led, wrote, closed, audited, trained
Scope
On what
Device type, class, number of products
Framework
Under which rules
MDR, IVDR, ISO 13485, ISO 14155
Result
What changed
Certificate kept, findings closed, study delivered
Responsible for technical documentation.
Led the MDR technical documentation update for a Class IIb product family and closed every notified body question in the first review round.
Illustrative wording. Use only what is true for you.
Six questions worth asking them
Where is your portfolio in the MDR or IVDR transition?
Tells you whether the job is remediation, maintenance or new launches.
Which notified body do you work with, and how are reviews going?
Signals workload and pressure in the coming year.
Where do RA and Quality sit, and who is the PRRC?
Reveals influence, reporting lines and growth room.
How do post-market data reach risk management and design?
Shows how mature the quality system really is.
Which markets come next?
Markets outside the EU, such as the US, can reshape the role.
What does success look like after six months?
Turns a vague role into a clear brief.
Your move
Before your next application, rewrite two CV lines with the four-part formula and pick two questions to ask.
08 · Sources and glossary
Go to the source. The primary sources behind our updates.
| Source | Watch for | Address |
|---|---|---|
| European Commission | Announcements, MDCG guidance, EUDAMED news. Separate announcements from obligations. | health.ec.europa.eu/medical-devices-sector_en |
| EUR-Lex | The legal texts, consolidated versions and application dates. | eur-lex.europa.eu |
| MDCG guidance | Endorsed guidance documents. Not binding: check the version and what it replaces. | health.ec.europa.eu, MDCG guidance page |
| EUDAMED | The EU database: actors, devices, certificates and its roll-out status. | ec.europa.eu/tools/eudamed |
| Harmonised standards | The list published in the Official Journal that gives a presumption of conformity. | health.ec.europa.eu, harmonised standards page |
| Team-NB | The European association of notified bodies: positions and practice papers. | team-nb.org |
| MedTech Europe | Industry data. An association source: check the data year. | medtecheurope.org |
Glossary · the acronyms you will meet most
- AR
- Authorised representative for non-EU manufacturers
- CAPA
- Corrective and preventive action
- CE
- EU conformity marking
- CER
- Clinical evaluation report
- CS
- Common specifications
- EUDAMED
- European database on medical devices
- GSPR
- General safety and performance requirements
- IVD
- In vitro diagnostic medical device
- IVDR
- In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
- MDCG
- Medical Device Coordination Group
- MDR
- Medical Devices Regulation (EU) 2017/745
- NB
- Notified body
- NCA
- National competent authority
- PMCF
- Post-market clinical follow-up
- PMS
- Post-market surveillance
- PRRC
- Person responsible for regulatory compliance
- PSUR
- Periodic safety update report
- QMS
- Quality management system
- SRN
- Single registration number in EUDAMED
- SSCP
- Summary of safety and clinical performance
- UDI
- Unique device identification
Hiring?
Put your next Regulatory Affairs, Quality or Clinical opportunity in front of the people it is meant for.
Start at vigilomedtech.com
Every Tuesday.
Relevant roles. Useful updates.
Questions or feedback
contact@vigilomedtech.comVigilo MedTech Jobs · Mendrisio, Switzerland · Edition 1, October 2026.
General information, not legal advice. Check the primary source before relying on any rule or date.