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Regulatory Affairs Specialist III

Pitcairn, PA

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Regulatory Affairs Specialist III
L&T Technology Services

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

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