Nathan Parker
Post Market Professional
Summerville,SC
Summary
Ambitious Medical Device Specialist with more than 7 years’ experience in the field. Shown to effectively work in a cross-functional team including Regulatory Affairs, Complaint Handling and Post Market Surveillance, holding all roles simultaneously.
Overview
6
6
years of professional experience
5
5
years of post-secondary education
Work History
Senior Complaint Analyst
Waters Corporation, Remote
Milford, MA
05.2017 - Current
- Analyzed Medical Device complaint data to identify root causes, trends, issues and regulatory concerns.
- Submitted MDRs based on complaint reportability
- Controlled backlog of clinical complaints to keep P90 and P50 metrics low
- Initiated and finalized CAPAs
- Worked cross functionally with Regulatory Affairs to draft, submit, remediate 510(k)s, PMAs, Technical Files
- Presented complaint data in monthly Complaint Review Boards and Post-Market Trend Review Meetings
- TrackWise, Compass, SAP
- Tracked, monitored and worked with stakeholders to address issues identified through root cause analysis.
Education
B.S - CHEMISTRY
08.2011 - 05.2016
Skills
Fluent in ISO 9001, 13485, EUMDR, Health Canada Regulations
IVD/Medical Device complaint handling
Regulatory submissions - 510(k), PMAs, MDRs
Medical Device Directives 93/42/EEC
Led multiple interdepartmental projects through to success
Implemented processes that led to 25% increased record submission per year
Timeline
Senior Complaint Analyst - Waters Corporation, Remote
05.2017 - Current
Keene State College - B.S, CHEMISTRY
08.2011 - 05.2016