Job Description : Cyient is a global engineering and technology solutions company.As a Design, Build, and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, in Job Description : Cyient is a global engineering and technology solutions company.As a Design, Build, and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, innovate, and stay ahead of the curve. We leverage digital technologies, advanced analytics capabilities, and our domain knowledge and technical expertise, to solve complex business problems. With over 15,000 employees globally, we partner with clients to operate as part of their extended team in ways that best suit their organization’s culture and requirements. Our industry focus includes aerospace and defence, healthcare, telecommunications, rail transportation, semiconductor, geospatial, industrial, and energy. Job Description Excellent working experience in Core Java, Spring framework, Database such as PostgreSQL and MySQL , MS SQL Server. Working experience on Spring framework, Spring Boot, Hibernate Experience 5+ years Should have good communication skills Angular experience is added advantage Skills & Experience Agile Methodologies, Angular2, AngularJS, AWS Cloud Services, Core Java, Hibernate, Java, Microsoft Azure, PostgreSQL, Relational Database Management System (RDBMS), Spring, SQL Cyient is an Equal Opportunity Employer. Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, veteran status, and other protected status as required by applicable law. We are proud to be a diverse and inclusive company where our people can focus their whole self on solving problems that matter. Monster 29 views

Cyient is a global engineering and technology solutions company.As a Design, Build, and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, innovate, and stay ah

Cyient is a global engineering and technology solutions company.As a Design, Build, and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, innovate, and stay ahead of the curve. We leverage digital technologies, advanced analytics capabilities, and our domain knowledge and technical expertise, to solve complex business problems. With over 15,000 employees globally, we partner with clients to operate as part of their extended team in ways that best suit their organization’s culture and requirements. Our industry focus includes aerospace and defence, healthcare, telecommunications, rail transportation, semiconductor, geospatial, industrial, and energy. Job Description Regulatory Affairs Specialist The Regulatory Affairs Specialist provides regulatory perspective and expertise to cross-functional teams to assure products can be marketed and are compliant with relevant medical device standards, codes and regulations. S/he provides medical device regulatory input to product labeling, including but not limited to product labels, Instructions for Use (IFUs), surgical techniques and translations. S/he develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. S/he relies on ongoing experience and judgment to plan, create, develop, and maintain materials needed for regulatory compliance. S/he uses technical knowledge to drive new product submissions, listings, and registration of medical devices. Trains and mentors lower level team members in regulatory activities. Duties/Responsibilities Understands regulations, follows complex directions, and investigates regulations when clarification is needed. Develops a working knowledge of the medical device regulations applicable to the devices being supported including, but not limited to: registration, labeling, and post-market surveillance requirements. In alignment with applicable strategies/plans and with support of team members, determines appropriate documentation and testing required for registration of products and coordinates with functional team members to obtain and provide this information. Prepares, organizes, and coordinates data for submission to and manages correspondence with the regulatory and standards agencies or organizations such as FDA, EU Notified Body, , EU Authorized Representative, and Third Party License Holders. Works with team members to conduct documentation reviews and change assessments including evaluation of effects of regulatory, design, and manufacturing changes, and helps determine required regulatory action (e.g. submissions, notifications). Assists in development, organization, and application of labeling (e.g. instructions for use, marketing materials, package labels, etc.), and may review and provide feedback on labeling and advertisement/promotional material to assure regulatory compliance. Provides regulatory perspective to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant US and international medical device standards, codes and regulations. Reports relevant regulation and standards changes and helps determine impact and/or appropriate action. Assures regulatory compliance and content accuracy of technical documentation and submissions. Completes research and other related assignments as required. Develops an expertise of the medical device regulations for assigned products. Determines applicable strategies /plans for products and works with functional and cross-functional team members to create, obtain, and provide this information. Works on development, organization, and application of labeling (e.g. instructions for use, marketing materials, package labels, etc.) reviews and approves labeling and advertisement/promotional material to assure regulatory compliance. Provides regulatory perspective and expertise to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant US and international medical device standards, codes and regulations. Reports relevant regulation and standards changes, determines impact and takes appropriate action. Ensures regulatory compliance of products and processes through participation in process updates. Attends meetings and/or follows trade organizations and publications to develop understanding of requirements in assigned markets. Trains and mentors team members on new or existing regulatory policies and processes in assigned markets. Supports internal and external (third party) audits as required. Qualifications Bachelor of Science in science and/or engineering field 5 years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered) Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device regulations, requirements, and standards. Experience in Orthopedics industry preferred. 510(k) experience andRegulatory Affairs Certification (RAC) preferred. Ability to work under limited supervision with FDA, Notified Body, Authorized Representatives, 3rd party license holders and other global regulatory agencies. Ability to support and execute activities related to product development teams and cross-functional projects. Ability to work well with others and manage projects. Excellent written and verbal communication skills.Proficient in Microsoft Office Ability to read and speak English sufficiently to read, understand, and complete all documentation. Regulatory Affairs Specialist The Regulatory Affairs Specialist provides regulatory perspective and expertise to cross-functional teams to assure products can be marketed and are compliant with relevant medical device standards, codes and regulations. S/he provides medical device regulatory input to product labeling, including but not limited to product labels, Instructions for Use (IFUs), surgical techniques and translations. S/he develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. S/he relies on ongoing experience and judgment to plan, create, develop, and maintain materials needed for regulatory compliance. S/he uses technical knowledge to drive new product submissions, listings, and registration of medical devices. Trains and mentors lower level team members in regulatory activities. Duties/Responsibilities Understands regulations, follows complex directions, and investigates regulations when clarification is needed. Develops a working knowledge of the medical device regulations applicable to the devices being supported including, but not limited to: registration, labeling, and post-market surveillance requirements. In alignment with applicable strategies/plans and with support of team members, determines appropriate documentation and testing required for registration of products and coordinates with functional team members to obtain and provide this information. Prepares, organizes, and coordinates data for submission to and manages correspondence with the regulatory and standards agencies or organizations such as FDA, EU Notified Body, , EU Authorized Representative, and Third Party License Holders. Works with team members to conduct documentation reviews and change assessments including evaluation of effects of regulatory, design, and manufacturing changes, and helps determine required regulatory action (e.g. submissions, notifications). Assists in development, organization, and application of labeling (e.g. instructions for use, marketing materials, package labels, etc.), and may review and provide feedback on labeling and advertisement/promotional material to assure regulatory compliance. Provides regulatory perspective to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant US and international medical device standards, codes and regulations. Reports relevant regulation and standards changes and helps determine impact and/or appropriate action. Assures regulatory compliance and content accuracy of technical documentation and submissions. Completes research and other related assignments as required. Develops an expertise of the medical device regulations for assigned products. Determines applicable strategies /plans for products and works with functional and cross-functional team members to create, obtain, and provide this information. Works on development, organization, and application of labeling (e.g. instructions for use, marketing materials, package labels, etc.) reviews and approves labeling and advertisement/promotional material to assure regulatory compliance. Provides regulatory perspective and expertise to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant US and international medical device standards, codes and regulations. Reports relevant regulation and standards changes, determines impact and takes appropriate action. Ensures regulatory compliance of products and processes through participation in process updates. Attends meetings and/or follows trade organizations and publications to develop understanding of requirements in assigned markets. Trains and mentors team members on new or existing regulatory policies and processes in assigned markets. Supports internal and external (third party) audits as required. Qualifications Bachelor of Science in science and/or engineering field 5 years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered) Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device regulations, requirements, and standards. Experience in Orthopedics industry preferred. 510(k) experience andRegulatory Affairs Certification (RAC) preferred. Ability to work under limited supervision with FDA, Notified Body, Authorized Representatives, 3rd party license holders and other global regulatory agencies. Ability to support and execute activities related to product development teams and cross-functional projects. Ability to work well with others and manage projects. Excellent written and verbal communication skills.Proficient in Microsoft Office Ability to read and speak English sufficiently to read, understand, and complete all documentation. Skills & Experience 21 CFR 820, FDA Medical Device Regulations, ISO 13485 Medical Devices, ISO 14971 Risk Management, Medical Device Directives, Medical Device Regulations Cyient is an Equal Opportunity Employer. Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, veteran status, and other protected status as required by applicable law. We are proud to be a diverse and inclusive company where our people can focus their whole self on solving problems that matter.

More Information

Only candidates can apply for this job.
Share this job
Company Information
  • Total Jobs 444 Jobs
  • Location INDIA

Contact Us

https://jobselevate.com/wp-content/themes/noo-jobmonster/framework/functions/noo-captcha.php?code=ee0a2