Approval, Qualification, Scale-Up — Staffed Before the Deadline Hits

A selection of two to four profiles is typically available within 24 to 36 hours. Three pieces of information are crucial: the product class, the type of facility, and whether the person will be required to interact with the Notified Body. From a network of over 23,000 vetted experts, positions in validation, regulatory affairs, and quality management can usually be filled on short notice.

Yes. Filtering is based on completed procedures, not on certificates: Which system was qualified, in which product class, and to what extent in terms of IQ, OQ, and PQ? An ISO 13485 certificate attests to a management system; a completed CAPA procedure attests to experience. During the interview, we ask about the nonconformity that caused the most trouble.

The median rate across all assignments is €1,050 per day. The rate depends on the role and level of responsibility: an interim regulatory manager is paid more than a quality engineer, while a validation engineer falls in between. Costs are typically 30 to 60% of those of traditional management consultancies. The range for each role is listed on the role page.

It shifts priorities, not responsibilities: Existing procedures continue while adjustments are discussed. In the BVMed Fall 2026 Survey, 62 percent of companies now prefer the FDA system over the EU MDR—the dual strategy for two markets ties up additional capacity. External support is worthwhile where documentation must be maintained for both systems.

The interim manager assumes a temporary line management role—in production, quality, or regulatory affairs—with the authority to issue instructions and responsibility for approvals and meetings with regulatory agencies. The freelance management consultant prepares decisions regarding portfolio, location, and make-or-buy. The subject-matter expert provides expertise in qualification, documentation, or test planning.

Yes, and that’s exactly where the need is greatest: 93 percent of medical technology companies in Germany have fewer than 250 employees. In such companies, there is no dedicated training department—just one person. If that person is unavailable, the process comes to a standstill. Temporary staffing bridges exactly this reliance on a single individual.

Typically, with a notice period of 5 to 10 days, depending on the agreed-upon term. Because training and certification processes have a defined end date, fixed-term staffing fits the project’s needs. Extensions are common, especially when the process evolves into ongoing support.

We will work with your legal or procurement department to clarify the contract type, reporting structures, work tools, and documentation before we begin. In regulated environments, there is also the question of who is authorized to approve documents—this must be clarified before we begin, not afterward. This does not replace legal advice.

Yes, provided that the cleanroom class, training, and shift schedule are included in the briefing. Experience with cleanroom protocols and Annex 1 requirements is a separate selection criterion. Documentation and analysis work, on the other hand, is often conducted in a hybrid manner.

The most in-demand roles are validation and process engineers, temporary regulatory affairs specialists, quality managers for CAPA and audits, and process engineers for yield and stability. In addition, there is demand for cold chain and supply chain specialists, as well as attorneys specializing in medical law. We’ll determine which role is the best fit for you during the briefing.

A temporary position is worthwhile when the task has a clear end: a certification, an approval process, an audit finding, or a plant expansion. A permanent position is worthwhile when the task is ongoing. Because over 80 percent of companies seeking to fill positions are unable to do so, temporary staffing is often the only way to meet a deadline.

Each profile undergoes an interview with a subject-matter expert and is evaluated against the job requirements: processes managed, including product category and scope; results achieved; and references from comparable mandates. The placement rate across all mandates is 95 percent.