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Director, Regulatory Affairs (Relocation to California/Utah)
Eingestellt von Real Staffing Group aus Frankfurt am Main
Projektbeschreibung
PRIMARY RESPONSIBILITIES:
* Management role responsible for the Company's regulatory affairs activities
* Represent Regulatory Affairs on project team and management meetings
* Provide management and leadership to the Regulatory Affairs organization in the development and implementation of strategies and processes
* Review advertising, labeling and public communications
* Review and approve change orders
* Responsible for worldwide regulatory filings, including: U.S. (510k), EU and other international markets
* Provide training, and mentoring to company personnel regarding regulatory strategies
* Act as company representative with US and International regulatory authorities
Assist in ensuring compliance to the Medical Device Directive (MDD) in the EU, Canadian Medical Device Directive
JOB REQUIREMENTS:
* 10+ Years experience in Regulatory Affairs (Device required)
* BA degree (scientific field a plus)
* Proven experience with at least 10 years interacting with regulatory agencies
* Hands-on experience with the preparation and submission of some or all of the following regulatory documentation, including 510(k) and PMA
To find out more about Real please visit www.realstaffing.com
Projektdetails
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Einsatzort:
Boston, Massachusetts, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Sonstiges