Post Market Data Analyst

Winston Salem, NC 27105

Posted: 08/05/2019 Employment Type: DirectHire Industry: Entry Level Job Number: 95354
We' re seeking a Post Market Data Analyst (Surveillance Specialist) to join our client, a family-owned medical device company in Winston-Salem! This is a permanent, Direct Hire position with a competitive salary and benefits package, and the opportunity to join a work environment that focuses on bringing people together, with collaborative working relationships that foster innovation. The primary purpose of this position is to collect, analyze, and report post market data, in compliance with national and international regulations and guidance. Responsibilities will include monitoring the performance of a medical device after the release to market, and ensuring post market surveillance plans and reports are completed and reported on time, including correspondence with Regulatory bodies, if applicable. The ideal candidate will have previous post market surveillance experience with knowledge of EU and USA reporting, and have strong organizational and analytical skills. If you feel you skill set aligns with this role and you' d be a good fit, we' d love to speak with you!

Responsibilities:
- 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

Requirements:
- 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.
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