Senior Post Market Surveillance Specialist Imricor Medical Systems Inc
Overview
Director of Quality exempt or non-exempt worksite in Burnsville MN offers base salary $110,000-132,000 plus benefits. Seeking candidate with expertise in post market surveillance and regulatory compliance.
What You'll Do11
- 1Assist Regulatory team in ensuring all global medical device reports are filed within regulatory timeframes
- 2Provide training on complaint reporting to other groups
- 3Perform and present post market trending analysis
- 4Ensure timely processing of complaints and maintain complaint database
- 5Collaborate independently with other departments and lead product complaint investigations
- 6Support inspections by regulatory agencies as requested
- 7Make sound decisions regarding medical device reporting to global regulatory agencies
- 8Use procedures judgment and experience to determine appropriate testing of returned products
- 9Conduct investigations with customers or field staff with minimal direction
- 10Authors post market surveillance plans and periodic safety update reports
- 11Performs other related duties as assigned
Requirements10
- 1Bachelor’s degree in applicable field
- 25+ years’ experience in Post Market Surveillance or related field
- 3Must be able to work independently under limited supervision
- 4Knowledge of global regulations for medical device reporting and complaint handling
- 5Experience with European Medical Device Regulations FDA 21 CFR Regulations Australian TGA Regulations ISO 14971 ISO 13485
- 6Strong communication skills both verbal and written
- 7Clarity of vision at 20 inches or less near vision
- 8Ability to identify distinguish colors
- 9Requires typing talking hearing
- 10Travel light work up to 20 lbs force required
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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