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Regulatory Affairs Specialist - Asia-Pacific (m/w/d) in der Städteregion Aachen
Referenznummer: acjobs-st-27052

Abiomed Europe GmbH - Vollzeitbeschäftigung
Start ab sofort - Online seit dem 12.04.2019


Abiomed is an innovative medical device company focused on recovering heartssaving lives with a single guiding mission: “Patients First.”
With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, GermanyTokyo, Japan, Abiomed’s 1,000+ employees form one of the fastest growing medical technology companies in the world.
We attractretain exceptional talent with our collaborative culture, commitment to employee professional development,we have an extraordinary leadership team that is authenticinspiring.
Regulatory Affairs Specialist – Asia-Pacific (m/w/d)
Provide regulatory assessments, as requested by HQ/Danvers, for project planningon-going product improvements
Distill Competent Authority requirementsadvise on strategic approach to meet themthe business objectives of Abiomed
Prepare initialchange submissions to competent authorities and,necessary, laboratories in the Asia-Pacific region
Createmanage Design Dossiers for medical devices according to local regulations
Monitor the Asia-Pacific regulatory landscape for upcoming changeshelp preparing Abiomed for such changes
Interface with HQ/Danvers to provide in-servicing/educate on the local requirements of targeted countries as requested
Review externalinternal reports for adequatenessusability for submissions
Give advice on questions of packaging, markinglabelling for the Asia-Pacific market
Perform the above functions for other Asian Pacific jurisdictions / markets, as requested by HQ/Danvers

Medical-technical training / University Degree as Graduate EngineerNatural Scientist with technical understanding
Recent experience with medical device approvals in TaiwanSouth Korea
Fluent in Englishat least one of the languages spoken in the Asia-Pacific region, e.g. Mandarin,Korean; good command of German
Willingable to travel up to 20% of the time to the Asia-Pacific region

An environment that is committed to patients as
Per our statement: Recovering Hearts. Saving Lives.®
Individual Career opportunities in a fast paced environment
An attractive remuneration package
Company events like FamilyPatient Day, Social Day, Team Events

Bitte geben Sie bei Ihrer Bewerbung die Referenznummer acjobs-st-27052 an.

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