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Senior Regulatory Affairs Specialist
Ref No.: 18-50127
Location: Salt Lake City, Utah
Position Type:Full Time/Contract
Start Date: 07/17/2018
TCS Profile Tata Consultancy Services (TCS) is a global leader in IT services, digital and business solutions that partners with its clients to simplify, strengthen and transform their businesses. We ensure the highest levels of certainty and satisfaction through a deep-set commitment to our clients, comprehensive industry expertise and a global network of innovation and delivery centers. TCS has been recognized by Brand Finance as one of the Big 4 Global IT Services Brands. Our continued industry-leading growth is a testament to the certainty our clients experience every day. TCS offers a consulting-led, integrated portfolio of IT, BPO, infrastructure, engineering and assurance services. This is delivered through its unique Global Network Delivery ModelTM, recognized as the benchmark of excellence in software development. A part of the Tata Group, India's largest industrial conglomerate, TCS has over 324,000 of the world's best trained consultants in 46 countries. The Company generated consolidated revenues of US $ 15.15 billion for year ended 31 March, 2015 and is listed on the National Stock Exchange and Bombay Stock Exchange in India. For more information, visit us at www.tcs.com. TCS delivers a level of certainty that no other firm can match—to our clients and to our employees. Come join us and experience certainty in your career.
RGS ID 2418889
RGS ID creation date
(dd-mmm-yy)
7-JUL-18
# of requirements 1
Job Title Senior Regulatory Affairs Specialist
Relevant Experience
(in Yrs)
8-10 years
Technical/Functional Skills
Must have skills*
• Min 8 years of Regulatory Affairs experience• Min 8 years of experience in the medical device industry• Engineering Background Required: Min BS in Engineering, MS preferred• Must have authored a 510(k)• Solid Understanding of US FDA and EU MDR, EU regulations and standards• Experience in preparing regulatory submissions• Experience interacting with FDA and/or other regulatory agencies/ notified bodies • Must work well in team environments• Must demonstrate leadership skills in team setting • Proven analytical abilities; Solid understanding of manufacturing and change control, and an awareness of regulatory trends

Good to have skills*
Candidates with experience in Design Quality preferred, Strong intuition/inquisitive/question asker/able to navigate ambiguity by leveraging previous experiences,Candidates with strong Writing skills will be preferred. Being able to communicate clearly in written format is essential.
Experience Required 8+ years with at least 5 years in Medical Device Industry
Roles & Responsibilities EU MDR Gap Assessment/ Remediation Strategy and Implementation, Review clinical protocols to be used in submissions, Prepare, review and file appropriate FDA pre-market submission to ensure devices are commercially available in the U.S.: preIDEs, IDEs, 510(k)s, PMA and PMA Supplements, Note to File (NTF), Represent RA as core team member on Sustaining Engineering projects, determine regulatory pathways, draft and approve regulatory documentation, Develop Regulatory Strategies for new or modified products and prepare project plans & budgets, Monitor and provide management with impact of changes in the Regulatory environment, Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management, Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators, Support Design Control process, Prepare Rational to File documentation for modifications to devices when appropriate, Participate in FDA & other notified body Inspections, Author and/or review regulatory procedures and update as necessary, Review change control documents and ascertain Regulatory impact for external and internal documents, Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information, Review promotional material and labeling for regulatory compliance.
Generic Managerial Skills The Senior R&D Engineer ensures project is as per schedule and provides guidance to team members, should be a self-starter and able to function with minimal guidance.
Education B.S. or B.A. degree required. MS preferred
Start date (dd-mmm-yy) 1-Sep-18
Duration of assignment (in Months) Long Term
Work Location (State, City and Zip) Salt Lake City, UT
Client Billing Rate $/hr
Rates payable to vendor $/hr
Key words to search in resume Medical Devices, US FDA, EU MDR, EU MDD, 510(k), PMA, Note to File, Regulatory Affairs
Prescreening Questionnaire The job profile requires working with cross functional team to ensure compliance to FDA and other applicable regulations. In this role, Consultant will mainly sustaining existing product lines by supporting review and implementation of Change Control Plans and ensuring compliance to regulations of various agencies. Supports applicable regulations including ISO, local, state, and/or federal requirements. Responsible for understanding product registration and re-registration requirements in various countries and working with local regulatory teams to support product lines