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| Firma: |
The Bryant Group |
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| Job-Titel: |
Regulatory Scientist |
| Job Kategorie: |
Pharma/Biotech |
| Arbeitsort: |
Indianapolis - IN Indiana - USA Vereinigte Staaten |
| Ref.-Nummer für Ihre Einträge: |
1279 |
| Stellen-Beschreibung: |
Develop and prepare technical content of documents related to testing of Class III and higher complexity Class II medical device submitted to regulatory authorities.
Write clear and accurate descriptions of pre-clinical testing and clinical studies of new medical products that will be used to support FDA and design dossier submissions.
Review requisite critical documentation for completeness and suitability for submission to regulatory authorities, both domestic and abroad as required.
Maintain knowledge of federal, state and any local regulatory requirements applicable to pre-market submissions for medical devices.
Develop and implement testing and regulatory strategies for new and existing medical devices.
Assess new technologies for regulatory compliance. Collaborate with product development, pre-clinical, and contract research organization teams. |
| Kenntnisse erforderlich: |
Ph.D in Science or Engineering. Candidates with a Masters degree may be considered with a minimum of 5 years experience in regulatory applications in the medical device industry. Preferred degrees include: Biological Science, Anatomy/Physiology, or Biomedical Engineering.
Ability to rapidly learn new technical subject matter that may be unrelated to area of formal training.
Ability to effectively and accurately communicate technical medical and scientific information to persons without expertise in the subject area.
Must be self-motivated and able to work in both an independent and collaborative setting.
Must have a desire and ability to lead positively and in union with the company’s vision and focus. |
Sprachkenntnisse: |
Englisch-Sehr Gut |
| Beschäftigungsart: |
Vollzeit |
| Jahresgehalt: |
90000 USD |
| Eintragsdatum: |
2008-01-22 |
| Grad der Ausbildung: |
Master |
| Ihre Erfahrung in Jahren: |
5 to 7 Years |
| Firma: |
The Bryant Group |
| Kontakt-Name: |
The Bryant Group |
| Bevorzugte Kontaktmethode: |
E-mail |
| Preferred Language of Resume/Application: |
English |
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