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| Company: |
The Bryant Group |
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| Job Title: |
Regulatory Scientist |
| Job category: |
Biotech |
| Job Location: |
Indianapolis - IN Indiana - USA |
| Job Reference Number: |
1279 |
| Job Description: |
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. |
Skills Required:: |
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. |
Language Requirements: |
English-Very Good |
| Employment Type: |
Full Time |
| Yearly Salary: |
90000 USD |
| Posting Date: |
2008-01-22 |
| Level of Education: |
Masters |
| Years of Work Experience: |
5 to 7 Years |
| Company: |
The Bryant Group |
| Contact Name: |
The Bryant Group |
| Preferred Method of Contact: |
E-mail |
| Preferred Language of Resume/Application: |
English |
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