What is Interim Management?

 

Interim management is the temporary provision of management resources and skills. Interim management can be seen as the short-term assignment of a proven heavyweight interim executive manager to manage a period of transition, crisis or change within an organization. In this situation, a permanent role may be unnecessary or impossible to find on short notice. Additionally, there may be nobody internally who is suitable for, or available to take up, the position in question. (Wikipedia)

 

What we do as interim manager?

 

Interim manager can be also understood as a project based on freelance or outsourced consulting of premium project. Typical is 20-30 h per week, however it could be full time too.

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With us you can profit from interim regulatory manager in whole lifecycle of medical device. It can be hybrid in DACH region or remote worldwide.

At the end of cooperation we want to show our key performance indicator, lessons learned report and outlook analysis.

 

As option you can bundle our unique selling service below in project:

• Online regulatory academy

• In-house workshop

• Regulatory newsletter

• Regulatory flat rate

 

When

 

It could be in whole lifecycle of medical device although we are specialist of RA/QA manager.

We are not limited to a complex topic in which we are assigned to solve the trouble but also in an acute project where in a short term the goal must be completed.

 

We list some examples:

• At early stage of product design

• During development and design

• At market release

• At product registration

• At deficiency by authority

• At inspection at and by any third party

• After product approval

 

In which discipline

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Regulatory affairs: pre-market analysis, product registration globally, clinical affairs

R&D: design control, V&V, outsourced testing

Product management: variant management, market launch plan and release

Quality management: change management, CAPA, inspection

Project management: in cross-disciplinary, over-continent, intercultural project

 

With whom

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We could work with all stakeholders upon your request.

Here are only some examples:

• Lead of regulatory and quality

• CEO, sponsor

• Lead of R&D

• International subsidiary

• International partner as consultant, supplier and dealer

 

How

 

Depending on contract in firm and country, we are flexible to have part time, full time project.

We prefer to be once one week at site of medical device manufacturer in DACH region.