REGULATORY ENGINEER, HIGH RISK COMPLAINTS Job Job in Skaneateles 13152, New York Us
REGULATORY ENGINEER, HIGH RISK COMPLAINTS
Company: Welch Allyn
Requisition #: 5439
Job Category: QA / RA
Location: Skaneateles, NY, US
Required Experience: 3 - 5 years
Required Education: Bachelors Degree
Travel Percentage: 0
Relocation Provided: No
Position Overview:
As a Regulatory Engineer, High Risk Complaints, you will implement the global adverse event management processes and procedures to ensure product complaints for Class I and II medical devices are adequately assessed for adverse event reporting. Utilizing your strong facilitation skills, you will lead cross-functional teams to thoroughly investigate critical complaints, perform and document reportability assessments, and analyze and escalate complaints as appropriate.
It's your life. Work well. You would be joining a privately held global manufacturer of innovative medical diagnostic equipment and solutions. Founded in 1915, Welch Allyn has been recognized as one of the Great Places to Work in the US, Ireland and Mexico.
Key Responsibilities:
Reporting to the Manager Regulatory Affairs, MDRS (Medical Device Reports), you will perform Post Market surveillance activities to ensure compliance to global regulations including FDA MDRs, Health Canada MPRs, and European vigilance reports through evaluation of high risk complaints for potential reportability and timely submissions.
You will work collaboratively with the Welch Allyn international site post market surveillance teams to ensure consistent assessment of high risk complaints.
Partnering with the Patient Safety and Risk Management teams, you will develop criteria to proactively identify and escalate complaints with potential safety, efficacy or performance issues.
You will facilitate cross functional teams comprising of Engineering, Risk, Quality, Service, and/or Marketing, to ensure comprehensive investigations of critical complaints are performed.
Required Background:
You have a BS Degree in Engineering or equivalent and experience working in a regulated industry, preferably with medical device. Your ability to manage priorities in a dynamic environment is imperative. You have excellent documentation, communication, problem-solving, leadership and judgment skills. You are equally comfortable working effectively as an individual contributor as well as a team member. Your experience with adverse event reporting (21 CFR 803) / failure investigations and complaint handling systems per Quality System Regulation (QSR) 21 CFR 820, ISO-13485 / CMDCAS and related standards is strongly preferred. Your solid technical background with an emphasis on patient monitoring devices and related technologies is desired.
Welch Allyn...What A Career Should Feel Like.