Jobbeschreibung

Positionsnummer / Reference Number

PA2202129072019

Position / Job Title

Senior Specialist Regulatory Affairs

Aufgaben / Tasks

• Formulation of regulatory strategies as well as preparation of technical documentation for various countries in the Asia Pacific Region

• Lively cooperation with various internal stakeholders (Manufacturing, R&D and Quality) with the aim to successfully register new products as well as evaluate the impact of changes to already existing products

• Supporting the preparation and conduction of Audits carried out by various notified bodies

• Direct communication with authorities, affiliates and partners located around the globe

Qualifikationen / Qualifications

• Scientific university degree paired with multiple years of experience working in regulatory Affairs within the medical device industry

• Good intercultural communication skills in combination with significant regulatory knowledge in Asian market

• Detail oriented way of working as well as flawless English skills in both verbal and written form (German and any other Asian language are a plus)

Weitere Informationen / Further Information

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