The European Union's medical-device regulation has, in effect, rewritten the medtech hiring plan for any company selling into the bloc. Add the parallel reforms across Japan, Singapore, and Australia, and the picture for a global medtech is not a single hiring market but a layered set of jurisdiction-specific obligations, most of which require people on the ground, or at least people with the right credentials in the right country.
This is the practical version of that picture. Where the new roles are concentrated, which roles internationalize cleanly through an Employer of Record, and which roles cannot, because the regulation itself names a person, a country, and a qualification.
This article is a spoke off our hub on why medical companies use Employer of Record. Read that first if you want the broader EOR rationale.
Why MDR and IVDR created a multi-year hiring bulge
Regulation (EU) 2017/745 (the Medical Devices Regulation, or MDR) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Regulation, or IVDR) replaced the prior medical-device directives with a regime that is broader in scope, stricter on clinical evidence, and far more demanding on post-market surveillance and economic-operator obligations.
The transition has been slower than originally planned. The Commission has extended MDR transitional deadlines twice. Regulation (EU) 2023/607 pushed legacy-device deadlines out to 2027 and 2028, and Regulation (EU) 2024/1860 further extended IVDR transitional provisions and introduced the Eudamed gradual rollout. The drivers were the same in both cases: notified-body capacity, manufacturer readiness, and the risk of devices dropping off the EU market.
Notified-body throughput remains the binding constraint. The Commission's MDCG 2022-14 and the subsequent capacity surveys published through the MDCG documents library have repeatedly flagged certificate-issuance backlogs, with the Commission and member states pushing structural and procedural fixes rather than relief from the underlying obligations.
For manufacturers that means a sustained, multi-year hiring bulge in:
- Regulatory affairs: specifically MDR/IVDR-experienced specialists who can author and maintain technical documentation under Annexes II and III.
- Quality assurance: ISO 13485-aligned QMS owners, internal auditors, CAPA leads.
- Clinical evaluation and PMCF: clinical evaluation report (CER) authors and post-market clinical follow-up leads, scoped to MDCG 2020-13 CER assessment expectations.
- Post-market surveillance and vigilance: PMS plan owners, PSUR authors, and incident reporting under MDR Articles 83-92.
- Person Responsible for Regulatory Compliance (PRRC): see the next section.
You can see the bulge in the larger players' disclosures. Medtronic's FY2024 10-K discusses ongoing investment in regulatory and quality systems tied to MDR transition; Philips' 2024 annual report describes continued quality-and-regulatory remediation spend; Boston Scientific's 10-K filings reference MDR-related compliance investment alongside ongoing regulatory operations build-out. Smaller manufacturers face the same workload at a fraction of the headcount, which is why hiring across borders is no longer optional.
The PRRC (Person Responsible for Regulatory Compliance) problem
This is the single most important constraint to understand before assuming that an EOR can solve EU hiring at the regulatory layer.
MDR Article 15, and the parallel IVDR Article 15, requires that manufacturers have available within their organization at least one Person Responsible for Regulatory Compliance with specified qualifications. The PRRC must hold either a relevant diploma plus one year of professional experience in regulatory affairs or quality management for medical devices, or four years of such professional experience. For micro and small enterprises the PRRC need not be employed but must be permanently and continuously at the company's disposal.
The MDCG has published MDCG 2019-7 on PRRC interpretation, and the authorized-representative guidance MDCG 2022-16clarifies the PRRC obligations on the EU authorized representative.
What this means in practice:
- The PRRC's responsibilities are personal and non-delegable in the way the regulation defines them: release of devices, technical documentation, post-market surveillance, vigilance, and clinical investigation conformity.
- For non-EU manufacturers, the EU authorized representative must designate its own PRRC (per Article 15(6)), in addition to the manufacturer's PRRC.
- An Employer of Record can put a qualified individual on payroll in the right country. It cannot itself be the PRRC, and it cannot designate one. The legal designation, the qualifications check, and the regulatory-correspondence chain run through the manufacturer (and, where applicable, the authorized representative), not through the EOR.
We say this clearly because some EOR marketing implies otherwise. EOR is a clean way to employ a qualified PRRC candidate in Germany, Ireland, or the Netherlands. It is not a way to outsource the PRRC role itself.
Which regulatory, quality, and post-market roles internationalize well
A non-exhaustive map of medtech roles where cross-border hiring through EOR is routine, versus where local presence and local qualifications dominate.
EU hubs: Germany, Ireland, Netherlands, Switzerland, Spain
Where the talent and the entities cluster.
Germany. The center of gravity for medtech regulatory and quality talent. Deep bench in active implantables, imaging, and orthopedics; high concentration of TÜV-trained auditors and ISO 13485 leads. Hiring an MDR specialist or quality engineer in Germany via EOR is one of the most common medtech use cases in our pipeline. Costs are higher than the EU median; works councils and the Kündigungsschutzgesetz shape termination practice.
Ireland. A medtech manufacturing and regulatory hub anchored by long-running operations from Medtronic, Boston Scientific, Stryker, and Abbott (see IDA Ireland's medtech sector page). English-language regulatory and quality bench, useful as an EU PRRC seat for US-headquartered manufacturers.
Netherlands. Strong on imaging, digital-health, and software-as-a-medical-device, pulled by Philips' historical center of gravity. English-language workplaces are the norm; the 30% ruling helps with senior international hires.
Switzerland. Outside the EU but a major medtech R&D base. Note that since the EU-Swiss MRA was not updated for MDR, Swiss manufacturers must designate an EU authorized representative to access the EU market, a structural reason Swiss medtechs maintain regulatory headcount in both countries.
Spain. Lower-cost EU hire with growing medtech regulatory and clinical-evaluation bench. Useful for CER authoring, PMCF, and post-market surveillance roles where senior judgment is needed but on-site presence is not.
For US-headquartered medtechs, Borderless AI's healthcare team regularly stands up first hires across these five jurisdictions in days, on owned entities, without pre-funding payroll.
APAC: Japan PMDA regime, Singapore HSA, Australia TGA
The honest summary: APAC medtech hiring is enabled by EOR for most operational roles and constrained by jurisdiction-specific responsible-person regimes for the regulated roles.
Japan, PMDA and the MAH framework. Japan's medical-device regime is governed by the Pharmaceuticals and Medical Devices Act, with the PMDA's English portal describing the marketing authorization holder (MAH) and Designated MAH (D-MAH) structure. A foreign manufacturer cannot simply employ a regulatory lead in Tokyo and call it done; the MAH must be a Japan-licensed entity carrying its own quality-management and safety-management responsibilities. EOR is well-suited to hiring commercial, clinical, and technical staff in Japan; it is not a substitute for the MAH or D-MAH.
Singapore, HSA. Singapore's Health Sciences Authority regulates medical devices under the Health Products Act, with registrant-and-importer obligations sitting with locally established entities. Operational and regional regulatory hiring through EOR is routine; the registrant role itself sits with a Singapore-registered company.
Australia, TGA sponsor responsibilities. The Therapeutic Goods Administration requires that an Australian sponsor be the legal counterpart for any device entered in the Australian Register of Therapeutic Goods. The TGA's sponsor responsibilities guidance is the practical reference. Again, EOR can employ commercial, clinical, and post-market staff in Australia; sponsor status sits with the entity.
The pattern across the region is the same: EOR removes the friction on hiring people. It does not satisfy the local-entity, locally-licensed responsible-person requirements that these regulators retain by design.
EOR vs entity for medtech: sample scenarios by company stage
A practical frame, not a recommendation.
Series A medtech, first EU hire. Likely a regulatory-affairs lead in Germany or Ireland, possibly the future PRRC candidate. EOR is almost always right here. Speed matters; entity setup at this stage burns cash that should be in the clinical program.
Series B / commercial-stage medtech entering EU. Three to six EU hires across regulatory, quality, and clinical. EOR remains efficient; consider entity in the country where you expect to put the PRRC and authorized-representative interface long-term.
Mid-cap medtech expanding into APAC. Country-by-country call. Japan and Australia push toward early entity establishment because of MAH and sponsor obligations. Singapore can run on EOR for some time. India, the Philippines, and Vietnam are typically EOR for the first 10 to 20 hires.
Large-cap medtech post-acquisition. EOR is the bridging tool while integration sets up. Several large medtechs use EOR specifically to retain acquired-team talent in countries where the acquirer does not yet hold an entity.
The general rule from the hub holds: EOR is usually cheaper below 10 to 20 employees per country and entity ownership is usually cheaper above. Medtech adjusts that rule with one extra factor: if a country's regulatory regime requires a locally established responsible person or sponsor, the entity decision may come earlier than headcount alone would suggest.
Honest limits
A few things an EOR cannot do for a medical-device company, no matter how the marketing reads.
- It cannot be the PRRC, or designate one. MDR Article 15 places the obligation on the manufacturer (and, separately, on the EU authorized representative). The EOR is the legal employer of the worker; the regulatory designation runs through the manufacturer.
- It cannot serve as the EU authorized representative. The authorized rep must be a legal person established in the Union and contractually bound under MDR Article 11.
- It cannot be the Japan MAH or D-MAH. Japan's PMA framework requires a licensed Japanese entity.
- It cannot be the Australian sponsor. The TGA sponsor must be Australian.
- It cannot replace ISO 13485 audits or notified-body engagement. Those run between the manufacturer, the notified body, and the regulator.
What an EOR does well is employ the qualified individuals who do this work, in the country where the regulation expects them to live. That is a meaningful unlock, but only if scoped honestly.
FAQs
Can an EOR employ our PRRC in Germany?
Yes. An EOR can be the legal employer of a qualified PRRC candidate in Germany or any other EU member state where it holds an entity. The PRRC designation itself, the qualification verification under MDR Article 15, and the regulatory accountability run through the manufacturer, not the EOR.
Do non-EU medtech manufacturers need an authorized representative?
Yes. Under MDR Article 11, any manufacturer not established in the EU that places devices on the EU market must designate a single authorized representative established in the Union. The authorized representative must itself have a PRRC under Article 15(6).
Where is the medtech regulatory talent concentrated in the EU?
Germany, Ireland, the Netherlands, and Switzerland are the densest regulatory and quality hubs. Spain and Portugal have a growing bench at lower cost, particularly for clinical evaluation, post-market surveillance, and software-as-a-medical-device roles.
Can an EOR satisfy Japan's MAH requirement?
No. The Marketing Authorization Holder under Japan's PMD Act must be a Japan-licensed entity with its own quality and safety management systems. EOR can employ Japan-based commercial, clinical, technical, and regulatory staff; it cannot act as the MAH.
Can an EOR be our TGA sponsor in Australia?
No. The TGA sponsor must be an Australian entity. EOR can employ Australian-based staff supporting your post-market and commercial work, but the sponsor role sits with a locally established legal entity.
Which medtech roles are easiest to hire cross-border?
MDR/IVDR-experienced regulatory affairs specialists, quality engineers, CER authors, post-market surveillance and vigilance specialists, SaMD engineers, and medical-device cybersecurity specialists are routinely hired through EOR. Roles that depend on a specific national designation (PRRC designation, authorized representative, MAH, TGA sponsor) are not.
Further reading
- Why Medical Companies are Turning to Employer of Record services
- How to Hire Clinical Research Associates Globally
- Hiring Medical Science Liaisons Internationally
- EOR for Biotech Startups on Tight Runway
- Global Hiring for Digital-Health and Telemedicine Companies
- How Tech Companies Are Turning to Employer of Record Services
