The statutory roles of German pharma and medtech: all fifteen named appointments

Most career advice in pharma talks about functions. Regulatory affairs, quality, medical affairs, sales. Useful, and incomplete, because Germany has a second layer that almost nobody maps: roles that exist because a statute says a named person has to hold them.

These appointments behave differently from ordinary jobs. Demand does not follow the market cycle, it follows the licence. A company that loses the person loses the ability to operate, sometimes within weeks. I spent 16 years recruiting in pharma, and named statutory responsibility on a CV was reliably the line that separated senior profiles from everyone else. This page is the map of all fifteen, with a guide behind each one, plus two engineering titles that get mistaken for appointments and are not.

The fifteen named roles at a glance

Manufacturing and quality

Four of the fifteen sit inside a plant. The sachkundige Person certifies and releases the batch, and § 15 AMG is unusually specific about what qualifies. Below that sit the Leiter der Herstellung and the Leiter der Qualitätskontrolle, whose responsibilities § 12 AMWHV requires to be written down and kept independent of each other. Where controlled substances are involved, a BtM-Verantwortlicher is appointed on top, per operating site rather than per company.

For career planning this cluster has a clear internal ladder. Quality control leadership is the usual step before a QP appointment, production leadership points toward site management, and the controlled substances mandate is the small niche that makes a quality profile hard to replace.

Distribution

Once a product leaves the plant it enters a different licence with its own named person. The verantwortliche Person under § 52a AMG owns the distribution quality system, qualifies suppliers and customers, and runs recalls. A Federal Administrative Court ruling in November 2020 confirmed that competence built through practical work counts, which opened the seat to people who had been told it belonged to pharmacists.

Safety and information toward the authorities

Two appointments face the regulator directly. The Stufenplanbeauftragter runs the German pharmacovigilance system and is the clearest route toward the EU QPPV. The Informationsbeauftragter answers for the correctness of product information and promotional claims, which makes it the one named role that sits close to marketing.

The field force

The largest group of all is regulated too. Anyone visiting healthcare professionals full-time to inform them about medicines is a Pharmaberater under § 75 AMG, whatever the job title says. Three qualification routes open that door, and the examined Pharmareferent is only one of them, which is the single most expensive misunderstanding in German pharma careers.

Cell and tissue

Tissue establishments run on their own authorisation. The verantwortliche Person under § 20c AMG comes with one of the most concrete qualification tests on this page: a degree in medicine, biology, biochemistry or a comparable field, plus at least two years of hands-on tissue processing. The candidate pool is correspondingly thin.

Veterinary medicines

Animal health has run on its own regulation since 28 January 2022, when Regulation (EU) 2019/6 replaced Directive 2001/82/EC. Article 97 names a sachkundige Person for veterinary medicinal products, the qualified person every holder of a veterinary manufacturing authorisation must have permanently at its disposal for batch release. The test is broader than the human one: a university degree in pharmacy, human medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology, plus two years of practical experience in undertakings that hold a manufacturing authorisation. Nothing in the text requires those years to have been served on a veterinary line, which is why a § 15 AMG qualified person clears Article 97 without effort while the reverse fails on a dual scope site, and why § 17 TAMG matters: it fixes what the German authority will accept as proof.

Medical devices, on both sides of the table

Device law names three people. At the manufacturer sits the PRRC under Article 15 MDR, the appointment that replaced the German Sicherheitsbeauftragter. In the field works the Medizinprodukteberater under § 83 MPDG, which is the legal gate into medtech field roles and the most reliable route out of clinical work into industry. Inside the hospital sits the Beauftragter für Medizinproduktesicherheit under § 6 MPBetreibV. When something goes wrong with a device, the same incident travels through all three.

Radiation protection

Ionising radiation brings its own appointment onto pharma sites, and it has nothing to do with the Arzneimittelrecht. Whoever holds a licence or files a notification under the Strahlenschutzgesetz is the Strahlenschutzverantwortlicher, and § 70 StrlSchG obliges that operator to appoint in writing, without delay, as many Strahlenschutzbeauftragte as leading or supervising the activity safely requires. The qualification is the Fachkunde im Strahlenschutz, tied to the application area, certified by the competent body and refreshed at least every five years under § 48 StrlSchV. Radiopharmaceutical production, PET centres, nuclear medicine, radiotherapy and analytical laboratories running X-ray equipment all carry the seat, often next to a sachkundige Person on the same site.

Dangerous goods

Transport law works the same way and catches far more companies than they expect. § 3 GbV requires an appointment in Textform, so a documented e-mail suffices since the 2025 amendment, once an undertaking is involved in carriage of dangerous goods and the GGVSEB or the GGVSee assigns it duties as a Beteiligter. The Gefahrgutbeauftragter then works to 1.8.3.3 ADR: monitoring, records in Textform, an accident report, and an annual report within six months of the financial year end. The qualification is an IHK Schulungsnachweis for each transport mode, valid five years, and the renewal examination has to be passed in the year before expiry or the full course starts again. Solvents, UN 3373 diagnostic samples, dry ice and lithium batteries in returned devices put most pharma and medtech sites in scope unless a § 2 GbV exemption applies.

Cosmetics, beside medicines law rather than inside it

This one belongs on the page for a reason recruiters keep getting wrong: the Cosmetics Regulation stands next to the Arzneimittelrecht, not under it, and a career built there does not read as pharma to a GMP inspector. Article 4 of Regulation (EC) No 1223/2009 lets no cosmetic product onto the EU market unless a legal or natural person established in the Community is designated as responsible person, which makes it the single seat here that a company can hold rather than a named human being. Article 5 loads that holder with the safety assessment under Article 10, the Produktinformationsdatei under Article 11, CPNP notification under Article 13, labelling under Article 19 and serious undesirable effects under Article 23. The Regulation prescribes no qualification for the role itself, because the diploma wording in Article 10(2) attaches to the Sicherheitsbewerter, the safety assessor, and mixing up the two bases is the mistake that ends the interview.

Two engineering titles that are not named roles

Two job titles show up in the same searches and belong in a different category altogether. The Pharmaingenieur and the Medizintechnik-Ingenieur are occupational descriptions. No statute names either of them, nobody is appointed to one, no authority is notified of the appointment, and there is no statutory qualification test to clear. That is why they are not in the table above, not in the count of fifteen, and why a CV cannot claim them as statutory responsibility.

What binds these jobs is the work rather than the person. EU GMP Annex 15 requires qualification and validation of premises, equipment and utilities, and § 12 AMWHV puts the duty to ensure those validations happen on the Leitung der Herstellung, so the engineer writes and runs the protocols that named person approves. On the device side Regulation (EU) 2017/745 addresses the manufacturer as a legal entity for technical documentation and clinical evaluation, while the MPBetreibV addresses the hospital as operator. That makes the engineering seat a feeder into the named roles instead of one of them, and a good one: four years running technical documentation already satisfies the experience route into the PRRC under Article 15 MDR, and a production department is the usual step before Leiter der Herstellung.

What these roles share, and why that matters for you

Read the fifteen together and a pattern shows up. The law almost always demands two things: expertise, and the ability to carry the duty continuously. The second half is where companies get into trouble, which is why deputy appointments exist and why the deputy seat is the springboard worth taking even without a pay rise.

A second pattern: several of these provisions protect the person. Article 15(5) MDR says the PRRC may suffer no disadvantage for doing the job properly, and § 6(3) MPBetreibV says the same for the safety officer. That language exists because the regulator expected the conflict between the release date and the release evidence. Bring it up calmly in an interview and you sound senior rather than difficult.

Third, and most useful when you write your CV: every one of these is a document a company must be able to show an inspector. If you have held one, or deputised for one, write it with dates and the legal basis. That single line is what recruiters and applicant tracking systems search for, which I cover in the guide on the ATS in pharma.

Frequently asked questions

How many statutory named roles does German pharma law create?

Counting the ones with career relevance, fifteen: seven under the Medicines Act and the AMWHV, one under Regulation (EU) 2019/6 for veterinary medicines, one under the Narcotics Act, and three in medical device law, of which one sits with the operator rather than the manufacturer. Outside medicines law come the Strahlenschutzbeauftragter under § 70 StrlSchG, the Gefahrgutbeauftragter under the GbV and ADR 1.8.3, and the responsible person under the Cosmetics Regulation. The Pharmaingenieur and the Medizintechnik-Ingenieur are not in that count, because no statute names them.

Can one person hold several of these appointments?

Often, yes. § 63a(2) AMG explicitly allows the Stufenplanbeauftragter to act as the sachkundige Person as well, and small companies routinely combine the wholesale, controlled substances and quality mandates. The clear exception is § 12 AMWHV, which requires production leadership and quality control leadership to stay independent of each other. The practical limit everywhere is whether the person can actually fulfil each duty continuously.

Do you need German for these roles?

For anything facing a German authority, solid German is the realistic expectation, because the file, the inspection and the correspondence run in German. The exceptions are the European appointments: the EU QPPV and the PRRC hire in English at international companies.

Which of these is the most reachable if you are trying to enter the industry?

The Medizinprodukteberater under § 83 MPDG, by a wide margin. A completed training in a medical field satisfies half the requirement, the employer supplies the product instruction, and clinical credibility is exactly what medtech field teams hire for.

Sources

Arzneimittelgesetz (AMG), full text (gesetze-im-internet.de, German)
AMWHV, full text (gesetze-im-internet.de, German)
Betäubungsmittelgesetz (BtMG), full text (gesetze-im-internet.de, German)
Medizinprodukterecht-Durchführungsgesetz (MPDG) (gesetze-im-internet.de, German)
§ 6 MPBetreibV, medical device safety officer (gesetze-im-internet.de, German)
Regulation (EU) 2017/745 (MDR) (EUR-Lex)
§ 70 StrlSchG, Strahlenschutzbeauftragter (freirecht.de, German)
§ 47 StrlSchV, erforderliche Fachkunde im Strahlenschutz (gesetze.legal, German)
§ 48 StrlSchV, Aktualisierung der Fachkunde (gesetze.legal, German)
§ 3 GbV, Bestellung von Gefahrgutbeauftragten (lexmea.de, German)
§ 8 GbV, Pflichten des Gefahrgutbeauftragten, Jahresbericht und Unfallbericht (lexmea.de, German)
LASI, Aufgaben des Gefahrgutbeauftragten nach 1.8.3.3 ADR/RID/ADN (lasiportal.de, German)
Regulation (EU) 2019/6, Article 97, qualified person responsible for manufacturing and batch release (legislation.gov.uk, English)
§ 17 TAMG, Nachweis der erforderlichen Sachkunde (lxgesetze.de, German)
Regulation (EC) No 1223/2009 on cosmetic products (EUR-Lex)
Article 10, Regulation (EC) No 1223/2009, safety assessment and the qualification wording (legislation.gov.uk, English)
EU GMP Annex 15, Qualification and Validation (europa.eu, English, PDF)
Medizinprodukte-Betreiberverordnung of 14 January 2025, full text (gesetze.legal, German)

© 28 July 2026 Andreas Schulz. All rights reserved. This overview is career guidance, not legal advice; the statutory text prevails.