Postmarket Surveillance Analyst II
168 Middlesex Turnpike Burlington, Massachusetts 01803
Voca has an immediate opening available for a Product Surveillance Analyst in Burlington, MA! Interested candidates will forward current resume to Chad Miller at email@example.com and call 952-303-8107. Thanks!
- On a daily basis, reviews and investigates all incoming customer comments related to product quality and patient safety.
- Oversees the input of information documenting same into the database.
- Position will feel like data entry, but it isn’t very simple. Takes risk events, if compliant, determines reportability to other governing agencies.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Preference for Health/Science Bachelor Degree. Open the Nurses (only candidates who would be considered with an Associate Degree).
- Looking for more of an analyst rather than coordinator.
- Time management skills essential for this role.
- Two or more years of complaint handling experience in a closely related field in the medical device and/or pharmaceutical industry or equivalent preferred.
- The demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential.
- Working knowledge of relevant Codes of Federal Regulations (CFRs) and International Organization for Standardization (ISO) regulations is a bonus but not required.
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