Nathan Parker
Post Market Professional
Summerville,SC
Overview
7
7
years of professional experience
5
5
years of post-secondary education
1
1
Language
Work History
Product Surveillance Specialist
Accuray Inc.
07.2023 - Current
- Conducted thorough investigations into customer complaints, gathering all necessary evidence to make informed decisions on resolutions.
- Worked closely with cross-functional teams to address product or service concerns raised by customers.
- Reduced complaint backlog
- Managed timeliness of complaint closure with engineer follow-ups
- Escalated complaints that meet potentially reportable criteria
Complaint Analyst
Waters Corporation
05.2017 - 06.2023
- 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
- Tracked, monitored and worked with stakeholders to address issues identified through root cause analysis.
Education
B.S - CHEMISTRY
Keene State College
Keene, NH 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
Certified Strength and Conditioning Coach
Certified barbell strength coach with clients across the USA for online coaching and locally for in person sessions.
Timeline
Product Surveillance Specialist
Accuray Inc.
07.2023 - Current
Complaint Analyst
Waters Corporation
05.2017 - 06.2023
B.S - CHEMISTRY
Keene State College
08.2011 - 05.2016
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