Regulatory Affairs Manager Medical Devices (m/f/d)

When you hear the words “Regulatory Affairs” your first thought is not how to manage you current Love affair, but how to bring new medical devices to the market?

Than you are the candidate we are searching for, as Regulatory Affairs Manager, for our customer an international manufacturer of modern medical devices.

Your role

•You are managing a Team of 3-4 Regulatory Affairs Specialists

•You are responsible for assessing compliance with the relevant regulation for in vitro diagnostic medical devices at national and international level (CE marking and US FDA)

•The evaluation of regulatory impact for product and process changes, definition of action plans to sustain conformity with applicable regulations and standards belongs to your daily work routine

•You are acting as regulatory referent within projects core team to support the introduction of new products on key markets (including US).

•You are developing, coordinating and implementing strategies to get market authorization according to project planning.

•You are supervising the preparation of documents for Worldwide registration

•You are responsible for the communication and reporting to supervisory authorities (BPDR), and notified bodies

•The evaluation and research of the relational literature and regulations, advice on all regulatory issues, the interpretation of directives and the design and implementation of internal regulations is also part of your role

•You are participating in association committees as well as standardization organizations

•Beside this you are conducting audits and trainings

Your expertise

•You have excellent management and organizational skills

•You are an experienced leader

•You bring a Degree in technical studies

•Your GMP knowledge is excellent

•You are experienced in licensing projects (FDA BLA’s, 510k’s)

•You have detailed knowledge of the Medical Devices regulatory framework (CE marking, CFR part 820,..)

•You are fluent in German and English

We are looking forward to get to know you!

Ansprechpartner:

Delia Heeger-Heß

email Delia.Heeger-Hess@hox.de
phone +4969870066411


Arbeitsort:

Langen


Kernkompetenzen:

Regulatory Affairs, Medical Devices, Führungserfahrung