Job ID: 11909

Regulatory Affairs Specialist (m/w/d)

Stellenart.

Festanstellung

Ihre Aufgaben.

Discover Impactful Work:
As a Regulatory Affairs Specialist (m/w/d) you will be responsible for the registrations, approvals and conformity assessments of our products in your area of responsibility during the various product life phases in Europe (CE marking according to IVDR (EU) 2017/746) and in global projects (with a focus on China, Japan, USA, Russia, among others).

A day in the Life:

  • You will compile technical documentation as well as registration dossiers for the products in your area of responsibility and independently lead the registration status of these products in coordination with the marketing organization.
  • internal and external contact person for the registration processes and keep yourself up-to-date on country-specific requirements.
  • Be an internal consultant for the planning and implementation of regulatory requirements in the product life cycle and you are involved in the planning and execution of audits with regard to regulatory requirements.

Ihr Anforderungsprofil.

Keys to Success:
Education

  • University degree in life science, engineering or technical education (MTA, BTA, PTA) with corresponding further education or professional experience.

Experience

  • 3 to 5 years of professional experience in the field of regulatory affairs
  • Professional experience in the segment „In-vitro“ diagnostics is desirable

Knowledge, Skills, Abilities

  • Solid knowledge of IVDD, GMP, ISO 13485, 21 CFR 820 and technical product standards.
  • You are an outgoing personality and have very good organizational and project management skills, are a strong communicator and enjoy working in a team and with different cultures
  • Structured, independent and autonomous working style
  • You are geared to find solutions with a high level of energy
  • Hands-on, very good command of written and spoken English, and minimum B2 (written/spoken) German knowledge.

Vorteile.

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Gehalt.

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