Strahlenschutzbeauftragter under § 70 StrlSchG: the named radiation protection appointment

Radiation protection is one of the few German compliance regimes where the named person appears on a licence file rather than in an organisational chart. The authority knows who you are. It holds your certificate, your written scope of duties and your employer's declaration of what you are allowed to decide.

That makes the Strahlenschutzbeauftragter, the radiation protection officer, a different kind of hire from a generic quality position. I have spent 16 years recruiting in pharma, eight of them at Bayer and five with large CROs, and the pattern with statutory functions repeats itself: the pool is small, the paperwork is unforgiving, and companies notice the gap when someone resigns and the licence file suddenly names nobody. The wider set of German named roles is collected in my overview of statutory functions in German pharma.

The statute and the duty to appoint

Two texts carry the regime. The Strahlenschutzgesetz (StrlSchG, Radiation Protection Act) and the Strahlenschutzverordnung (StrlSchV, Radiation Protection Ordinance), both in force since the end of 2018, when the old Röntgenverordnung was folded into them.

§ 69 StrlSchG defines the Strahlenschutzverantwortlicher, the responsible party. It is whoever needs a licence under the Act, including under § 12(1), and whoever files a notification under it, including under § 19. Where that party is a legal entity or a partnership, the persons authorised to represent it exercise the function. If there are several, the competent authority must be told which of them takes on the tasks, and § 69(2) states that the collective accountability of all members of the governing body stays untouched.

§ 70(1) StrlSchG sets the appointment duty. The operator has to appoint the necessary number of Strahlenschutzbeauftragte in writing and without delay, for the leadership or supervision of an activity, so far as that is necessary to ensure radiation protection. Sentence 2 makes clear that the appointment does not release the operator from responsibility. § 70(2) requires the tasks, the internal decision-making area and the necessary powers to be recorded in writing, and limits the appointee's duties to that recorded scope. § 70(3) admits only persons whose reliability raises no concerns and who hold the required Fachkunde. § 70(4) requires written notification to the authority, with the tasks, the powers and the Fachkunde certificate, and copies to the appointee and to the works or staff council.

What the job actually is

The daily content is control of exposure. Setting up and policing radiation protection areas, dose monitoring for occupationally exposed workers, activity balances in and out, shielding and interlocks, decay storage and waste, contamination checks, instruction of personnel, the written Strahlenschutzanweisung under § 45 StrlSchV, which § 73 StrlSchG authorises, and the records that let an inspector reconstruct a year of operations. In nuclear medicine and radiopharmacy the activity ledger is the heart of it, because unsealed radionuclides move between synthesis, dispensing, patient and waste on the same day.

§ 71 StrlSchG governs how the two roles work together, and candidates should read it before accepting an appointment. The operator has to inform the appointee without delay of every administrative act and measure touching the appointee's tasks or powers. The appointee has to report deficiencies without delay. Where the two cannot agree on the corrective measures proposed, the operator must reject them in writing with reasons and send copies to the works or staff council and to the competent authority. If the operator skips that notification, the appointee may go to the authority directly. That escalation route is the real power in the role, and the reason the seat gets uncomfortable when management treats radiation protection as a scheduling obstacle.

The Fachkunde the law demands

§ 74(1) StrlSchG states the general rule: "Die erforderliche Fachkunde im Strahlenschutz wird in der Regel durch eine für das jeweilige Anwendungsgebiet geeignete Ausbildung, durch praktische Erfahrung und durch die erfolgreiche Teilnahme an von der zuständigen Stelle anerkannten Kursen erworben." Suitable education for the application area, practical experience, and passing recognised courses. All of it tied to what you will actually supervise.

§ 47 StrlSchV sets out the proof. The competent body examines the acquisition of Fachkunde and certifies it, and that certificate is what the authority wants under § 70(4). The file carries evidence of training, a written confirmation of practical experience from a supervisor naming the activities, their periods and the facility, and proof of successful course participation, which should not be older than five years at the point of application. § 47(4) allows recognition of comparable qualifications acquired abroad. § 47(6) treats the licence under the MT-Berufe-Gesetz as sufficient for medical technologists for radiology within their reserved activities. The Bundesamt für Strahlenschutz puts the practical experience component at anything from a few months up to three years depending on the task.

The refresher obligation is the number people get wrong in interviews. § 48(1) StrlSchV: "Die erforderliche Fachkunde im Strahlenschutz muss mindestens alle fünf Jahre durch eine erfolgreiche Teilnahme an einem von der zuständigen Stelle anerkannten Kurs oder anderen von der zuständigen Stelle als geeignet anerkannten Fortbildungsmaßnahmen aktualisiert werden." At least every five years, with proof to be produced to the competent body on request. § 48(2) lets that body accept another route in an individual case, provided it delivers knowledge equivalent to a course under paragraph 1.

Fachkundegruppen and which one applies to you

Fachkunde is not a single certificate. It is granted for an Anwendungsgebiet, an application area, and guidelines issued under § 74 StrlSchG and § 47 StrlSchV set out how those areas are cut. A new set took effect in 2026 and replaces the instruments most course brochures still quote.

The general one is the "Rahmenrichtlinie über die erforderliche Fachkunde und die erforderlichen Kenntnisse im Strahlenschutz nach § 74 Strahlenschutzgesetz und § 47 Strahlenschutzverordnung (Rahmen-RL FK)", circulated on 26 June 2026 and to be applied by the Land authorities from 1 January 2027 at the latest. For work outside application to humans and outside veterinary medicine the reference is the "Richtlinie über die erforderliche Fachkunde und die erforderlichen Kenntnisse im Strahlenschutz außerhalb der Anwendung am Menschen oder der Tierheilkunde (FK-RL Technik)" of 26 June 2026. Its Anhang 1 splits the field into three parts: Bereich R for operating Röntgeneinrichtungen and Störstrahler, Bereich S for handling radioactive substances, Bereich A for facilities generating ionising radiation. Each Fachkundegruppe carries a code and a set of course modules, so a certificate states the group it covers. In Bereich S the activity handled is graded against the Freigrenze, the exemption limit. S4.1 covers handling unsealed radioactive substances up to 10⁵ times that limit, S4.2 above it. Section 8.2 sets the deadline: from 1 January 2027 the competent body is only to recognise courses that match the guideline.

Application to humans runs on its own instrument, the "Richtlinie über die erforderliche Fachkunde im Strahlenschutz für das ärztliche und zahnärztliche Personal bei der Anwendung am Menschen (FK-RL Medizin)", circulated on 30 June 2026 and likewise to be applied from 1 January 2027 at the latest. It sorts requirements into Strahlentherapie, Nuklearmedizin, Röntgendiagnostik and zahnmedizinische Röntgendiagnostik, and it supersedes the 2005 guideline on X-ray equipment in medicine and dentistry together with the 2011 Richtlinie Strahlenschutz in der Medizin. Treat a group code in a job ad as an indication, then check the guideline and the authority's own practice.

Verantwortlicher against Beauftragter, and who carries what

The split is often misdescribed in job ads. The Strahlenschutzverantwortlicher carries the operator duties under § 72(1) StrlSchG and stays responsible after appointing anyone. The Strahlenschutzbeauftragter is responsible under § 72(2) for compliance within the tasks assigned, and only within them, which makes the written scope under § 70(2) the most important document in your personal file.

The statute does not declare the appointee free from instructions. What it gives is narrower and, in practice, sharper. § 70(6) forbids obstructing the appointee in performing the duties and forbids disadvantaging them because of it. Where the appointee is employed by the operator obliged to make the appointment, termination is prohibited except for cause, and that bar runs for one year after the appointment ends. Alongside that sits the § 71(2) right to approach the authority.

§ 70(5) is the provision that kills paper appointments. The authority may determine that a person may not act as Strahlenschutzbeauftragter where the powers granted are insufficient, or the Fachkunde or reliability is lacking, or the person cannot properly fulfil the duties. A seat offered without budget, without stop authority and without time is not a career step. It is exposure.

Who appoints one in pharma and medical technology

Radiopharmaceutical manufacturers sit at the centre. Handling radioactive substances requires a licence under § 12(1) StrlSchG, running in parallel with the AMG manufacturing authorisation and its own named functions, so a radiopharmacy site typically has a Strahlenschutzbeauftragter next to a sachkundige Person and the heads of production and quality control. PET centres add a layer, because operating a cyclotron is the operation of a facility generating ionising radiation under § 12(1).

Then the clinical side. Nuclear medicine departments and practices, radiotherapy, radiology, and hospitals operating X-ray equipment, where § 19 StrlSchG splits operation into a notification route with a two week lead time and a licence route for uses including treatment of humans, teleradiology and mobile operation. Trial sites running imaging endpoints belong here too, and where radiation is applied to humans for medical research purposes, § 31 StrlSchG and following add a separate licence and § 32 and following a notification route. The Bundesamt für Strahlenschutz grants the licence under § 185(1) StrlSchG. The notification moved from the BfS to the BfArM and the Paul-Ehrlich-Institut on 1 July 2025 through the Medizinforschungsgesetz. Sponsors and CROs underestimate that step regularly.

Outside the clinic the demand is quieter and steadier. Analytical laboratories with X-ray diffraction and fluorescence equipment. Quality control departments running industrial radiography or X-ray inspection lines. Manufacturers of irradiation and imaging devices, including service organisations whose engineers work inside customers' controlled areas. Companies that also place medical devices on the market often run this seat near the PRRC under Article 15 MDR, though the two have nothing to do with each other legally.

Licensing and supervision sit with the Länder, so the answer to "which authority" depends on your postcode. Regierungspräsidien, Gewerbeaufsicht, Landesämter and city authorities all appear. The body that certifies Fachkunde differs again, with the Ärztekammern issuing certificates for physicians and state authorities handling the technical side.

The routes in and what a CV has to evidence

Almost nobody plans this career. A radiochemist takes over the isotope laboratory. A medical physicist in nuclear medicine adds the appointment to the dosimetry work. A production supervisor at a PET site does the S course because the licence needs a second name. The deputy appointment is the usual first rung, since operators need continuous cover and the authority has already seen the deputy's file.

What a CV has to show is specific and mostly ignored. Name the application area and the Fachkundegruppe of every certificate you hold, with the issuing body and the date, plus the date of your last Aktualisierung under § 48 StrlSchV, because a lapsed refresher makes you unappointable until you fix it. State the nuclides and activity ranges you have worked with, sealed or unsealed, and whether the site ran a licence under § 12 StrlSchG or a notification under § 19. List authority inspections with the year and your part in them. If you have held the appointment, write the exact German title and the dates, and say what your § 70(2) scope covered. Recruiters and applicant tracking systems search the German strings, so Strahlenschutzbeauftragter, Fachkunde im Strahlenschutz and Umgangsgenehmigung belong in the document literally; how that filtering works is in my guide on the ATS in pharma.

On pay I will not quote a band, because I have no source I would stand behind. What moves the number is the surrounding role rather than the appointment, since the seat is almost always attached to a scientific, medical or engineering position. A medical physicist in a university hospital and a service manager at a device manufacturer sit in different pay systems, one of them collectively agreed. The appointment adds bargaining power rather than a fixed allowance, and that power is real when a licence depends on your name.

Frequently asked questions

Does every company with radiation sources need a Strahlenschutzbeauftragter?

Not automatically. § 70(1) StrlSchG requires the operator to appoint the necessary number for the leadership or supervision of an activity, so far as that is necessary to ensure radiation protection. Where the Strahlenschutzverantwortlicher is a natural person who holds the required Fachkunde and personally directs the activity, the NRW labour inspectorate's advisory service takes the view that no appointment is compelled, while still recommending one to cover holiday and sickness. The licence or notification file has to satisfy the authority either way, and the authority decides. Ask the competent Land authority before you assume you are exempt.

How often does the Fachkunde have to be refreshed?

At least every five years, under § 48(1) StrlSchV, through successful participation in a course recognised by the competent body or other continuing education it accepts as suitable. Proof has to be produced to the competent body on request, and § 48(2) allows an alternative route in an individual case where the knowledge conveyed matches that of a course under paragraph 1. Separately, § 47 StrlSchV expects course participation submitted with a Fachkunde application to be no older than five years.

Can I be dismissed for insisting on a radiation protection measure?

§ 70(6) StrlSchG forbids obstructing the appointee in performing the duties and forbids disadvantaging them because of it. Where you are employed by the operator obliged to make the appointment, terminating that employment is prohibited except for cause, and the bar runs for one year after the appointment ends. Where the operator refuses a proposed measure, § 71(2) requires a written rejection with reasons and copies to the works council and the authority, and lets the appointee approach the authority directly if that notification is skipped.

Is the Fachkunde transferable between employers and application areas?

The certificate is personal and stays with you, but it is issued for an application area, so moving from an X-ray inspection line to an unsealed-radionuclide laboratory generally means a further course and further practical experience. A new employer still has to appoint you afresh in writing under § 70(1) and notify the authority under § 70(4) with your certificate attached. Check with the receiving authority early, because recognition practice differs between the Länder.

Sources

§ 69 StrlSchG, Strahlenschutzverantwortlicher (lxgesetze.de, German)
§ 70 StrlSchG, Strahlenschutzbeauftragter, full text of paragraphs 1 to 7 (freirecht.de, German)
§ 70 StrlSchG, second reading of the appointment duty (urteile-gesetze.de, German)
KomNet, besonderer Kündigungsschutz für Strahlenschutzbeauftragte nach § 70 Absatz 6 StrlSchG (komnet.nrw.de, German)
KomNet, Bestellpflicht wenn der Strahlenschutzverantwortliche die Fachkunde selbst besitzt (komnet.nrw.de, German)
§ 71 StrlSchG, betriebliche Zusammenarbeit im Strahlenschutz (lxgesetze.de, German)
§ 72 StrlSchG, weitere Pflichten des Strahlenschutzverantwortlichen und des Strahlenschutzbeauftragten; Verordnungsermächtigung (lxgesetze.de, German)
§ 73 StrlSchG, Verordnungsermächtigung für den Erlass einer Strahlenschutzanweisung (lxgesetze.de, German)
§ 74 StrlSchG, Erforderliche Fachkunde und Kenntnisse im Strahlenschutz; Verordnungsermächtigungen (freirecht.de, German)
§ 12 StrlSchG, Genehmigungsbedürftige Tätigkeiten (freirecht.de, German)
§ 19 StrlSchG, Genehmigungs- und anzeigebedürftiger Betrieb von Röntgeneinrichtungen (lxgesetze.de, German)
§ 47 StrlSchV, Erforderliche Fachkunde im Strahlenschutz (gesetze.legal, German)
§ 48 StrlSchV, Aktualisierung der Fachkunde (gesetze.legal, German)
§ 45 StrlSchV, Strahlenschutzanweisung (lxgesetze.de, German)
Rahmen-RL FK of 26 June 2026, framework guideline on the required Fachkunde (bundesumweltministerium.de, German)
FK-RL Technik of 26 June 2026, full text with Anhang 1 and the Fachkundegruppen (bundesumweltministerium.de, German, PDF)
FK-RL Medizin, circular of 30 June 2026, to be applied from 1 January 2027 (bundesumweltministerium.de, German)
Bundesamt für Strahlenschutz, Aus- und Weiterbildung im Strahlenschutz (bfs.de, German)
Bundesamt für Strahlenschutz, Anzeige und Genehmigung bei Strahlenanwendung zum Zweck der medizinischen Forschung (bfs.de, German)
Arbeitsschutz NRW, Bescheinigung der Fachkunde durch die zuständige Stelle (arbeitsschutz.nrw.de, German)
LAGetSi Berlin, neues Strahlenschutzrecht ab 31. Dezember 2018 und Aufhebung der Röntgenverordnung (berlin.de, German)
BMUKN, Wann ist das neue Strahlenschutzgesetz in Kraft getreten (bundesumweltministerium.de, German)

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