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| Job ID: 37766 |
Job Views: 223 |
Location: Boston, Massachusetts
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Job Category: Other |
| Employment Type: Full time |
Salary: $ 135,000 per year |
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Posted: 05-13-2010 |
Occupations:
Medical-Health : Dental Assistant-Hygienist, Dental Practitioner, EMT-Paramedic, General-Other: Medical-Health, Healthcare Aid, Laboratory-Pathology, Medical Imaging, Medical Practitioner, Medical Therapy-Rehab Services, Mental Health, Nursing, Nutrition and Diet, Optical, Pharmacy , Physician's Assistant-Nurse Practitioner, Public Health Administration, Social Service, Sports Medicine, Veterinary-Animal Care
Other : Career Fair, Other, Work at Home
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Job Description:
Responsible for managing US regulatory and clinical research functions to ensure compliance with FDA requirements for complaint handling, medical device reporting, corrective and preventive action systems, good clinical practice adherence, and company marketing protocols.Coordinates, drafts, and manages regulatory pathways for FDA submissions, including but not limited to 510(k)s, PMAs, and IDEs in close collaboration with global regulatory function.
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Job Requirements:
Experience negotiating and interfacing with US FDA.
Experience with US FDA and ISO inspections.
Minimum 6 years of experience in the medical technology company with both regulatory and clinical activity exposure.
Minimum of at least 2 years managing regulatory group within a medical technology company.
Demonstrated ability to lead functional team and operate within a global, matrix-management environment.
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