Jobbeschreibung

Positionsnummer / Reference Number

PA2202118092020

Position / Job Title

Specialist Regulatory Compliance

Aufgaben / Tasks

• Coordinate and consult with various stakeholders concerning the "quality" of CERs

• Ensure cross departmental alignment in terms of time and content and regarding the nearing MDR deadlines

• Facilitate and orchestrate a flawless registration process with the responsible authorities through optimally impacting the registration strategy for multiple products in various indications

• Take part in risk assessment activities, the review of regulatory documentation and marketing materials as well as the maintenance of the respective SOPs

Qualifikationen / Qualifications

• Relevant degree in the field of natural sciences

• Multiple years of experience in authoring CERs as well as with all the research - and analysis - related tasks involved

• Solid understanding of the respective regulatory guidelines and their implications on the individual documents needed for registrations

• Ability to work and plan strategically in addition to immaculate English skills in both verbal and written form (The ability to communicate in German is appreciated)

Weitere Informationen / Further Information

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