Post Market Data Analyst
Winston Salem, NC 27105
- Collaborate with functional teams to collect, review, and analyze data for the Post Market Surveillance (PMS) process
- Review metadata for medical devices once they are on the market (including CAPA, quality, adverse event, field actions, clinical literature, etc.) and assess benefits versus risk
- Schedule and facilitate Post Market Surveillance meetings to discuss plans and reports
- Collect, review, and edit Post Market Surveillance data for Clinical Evaluation Reports
- Generate plans and reports to ensure compliance with evolving regulations
- Monitor, track, and communicate project progress to leadership
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements
- Generate responses to inquiries on PMS reports from various global regulatory authorities
- Bachelor' s degree in a technical discipline or communications, or equivalent work experience
- 2-3 years related Post Market Surveillance experience required
- Computer experience required with working knowledge of Microsoft Office programs
- Proficient keyboarding skills
- General product knowledge
- Medical device industry regulatory requirements knowledge
- Knowledge of EU and USA reporting
- Ability to prioritize workload and meet project deadlines
Submit your resume online, or send directly to ckelly-corne@theresource.Com to be considered for this position. For additional information, please call 336.970.5208.
While we appreciate all inquiries, only qualified candidates will be contacted for further information.
When applying online, please select ' Permanent Recruitment' when asked to select a branch to begin.