Job added in hotlist
Applied job
Contract job
90-day-old-job
part-time-job
Recruiter job
Employer job
Expanded search
Apply online not available
View more jobs in Pitcairn, PA
View more jobs in Pennsylvania

Job Details

Regulatory Affairs Specialist III

Location
Pitcairn, PA

Apply for this job






3 hit(s)  

Profile

Regulatory Affairs Specialist III
L&T Technology Services

Pitcairn
PA
Job #684942497
Position Description L&T Technology Services is a global leader in providing World Class engineering solutions to our customers in the Medical Devices Industry. Now you can be part of that cutting-edge team and provide your expert knowledge of Regulatory Affairs, specifically pertaining to the market and requirements for the European Union in this exciting, challenging role based in Monroeville, PA. In this role, you will provide strategy, direction, and guidance as related to the European Union Medical Device Regulations for our customer at the customer facility. Responsibilities Work independently on Regulatory duties, processes, and roles Create and update:European Technical File Declaration of Conformity Classification Documents Ensure documents created are in conformity with European Medical Device Regulations (EU MDR) Communicate identified gaps and track the status of action items through closure Collaborate with the project team(s) to ensure action items are attended Review and approve product labeling plans, physical labeling, and marketing communications Support EUDAMED database activities including data collection and uploads Support QMS System Updates for compliance with EU MDR Support internal and external quality audits Provide regulatory training and guidance assigned to new product development as well as sustaining projects within the Medical Devices industry as related to EU MDR Required Knowledge & Skills Bachelor’s Degree in a relevant technical field is required; Master’s Degree is strongly preferred Eight or more years of hands-on regulatory affairs experience, specifically working on projects in compliance with European regulations and standards Significant leadership experience, with a proven track record of implementing change and providing strategy and direction on critical projects Must Have experience within the Medical Devices industry – other industry experience will be considered alongside hands-on Medical Devices experience Experience with ventilators strongly preferred Experience with Design Controls strongly preferred Proficient knowledge of medical devices regulation (21CFR), FDA Regulations, MDD, other global laws and regulatory standards including:ISO:14971 IEC:60601 Must have hands-on experience with successful preparation and submission of 510(k) submissions Experience writing Clinical Evaluation Reports (CERs) that are compliant with MEDDEV 2.7.1 revision 4 Knowledge of the impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on manufacturers and notified bodies RAPs RAC strongly preferred ASQ Certification strongly preferred Requires strong written, oral, and interpersonal skills to successfully collaborate with key project stakeholders at all levels of the organization and with varying degrees of technical expertise Requires a strong understanding of LEAN concepts, methodologies, and deployment May require 5% travel annually, including domestic and international destinations
Updated 06/13/2018

Company info

Sign Up Now - ComplianceCrossing.com

Similar Jobs:
Compliance Program Manager Sr
Location : Pittsburgh, PA
\u003Cdiv\u003E\u003Cstrong\u003EPosition Overview\u003C/strong\u003E\u003C/div\u003E\u003Cdiv\u003E\u003Cfont style='\\\font-size:11px;\\\'\u003E\u003Cspan class='\\\questionInput\\\'\u003E\u003Cspan class='\\\questionInput\\\'\u...
Independently contributes to the compliance efforts of multiple assigned business units. Responsible for assisting the business units to bring them into compliance with complex regulatory and policy requirements. In partnership wi...
Administrator, Medicare Compliance
Location : Pittsburgh, PA
Administrator, Medicare Compliance in Pittsburgh Pennsylvania Description Purpose:UPMC Health Plan is seeking an Administrator- Medicare Compliance! The position incumbent will report directly to the Manager, Medicare Compliance. ...
I was facing the seven-year itch at my previous workplace. Thanks to EmploymentCrossing, I'm committed to a fantastic sales job in downtown Manhattan.
Joseph L - New York, NY
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
ComplianceCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
ComplianceCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2018 ComplianceCrossing - All rights reserved. 169