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Regulatory Affairs Specialist EMEA & APAC

Institut Straumann AG

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Straumann partners with passionate people who fit in with the agile dynamics of our size-for success company. People at Straumann appreciate the opportunity to shape our future and cre ate impact. Encouraging leadership and inspiring ideas from our people has guided us through our proud history of pioneering innovations.
In your role as a passionate and performance driven Regulatory Affairs Specialist you will be responsible for the overall product registration strategies, coordination, implementation, execution, control and completion of product registrations world-wide except US. The role is based at our Headquarters in Basel.

Regulatory Affairs Specialist EMEA & APAC

Preparing the Technical File for international registrations
Registration of the new products world -wide except US
Product lifecycle management and product license maintenance
Set up registration strategies; execute registration process from dossier
compiling to submission and approvals of assigned products throughout various
regions University degree in a scientific discipline such as biology , pharmacy,
chemistry, engineering or equivalent
5 years' experience in General Regulatory Affairs, with at least 2 years of
international regulatory experience
Profound experience with international medical device (class II & III)
regulatory approvals and submissions
Proven track record of successful interactions with Health Authorities
Excellent command of spoken and written English; any other language is an asset
Effective communication and persuasion skills to interact across different
levels and cultures
Results-oriented in a dynamic environment
Agility to handle and deliver on a multitude of projects, programs, and
priorities paired with high sense for execution and teamwork
Accountable personality with a structured and pragmatic working style
Ability to build trust and drive engagements in others in a constantly changing
environment
Collaborative, emphatic and solution oriented individual It takes the commitment of bright and resourceful people to further advance our
innovative technology as well as our Swiss standard of precision and quality.
Adding your passion to our high-performance culture is a smart move. Are you
interested in a challenging job at Straumann? If so, please forward your
application to:
(Please note that we do not accept applications neither CV's from any
recruitment agencies.)