Net2source
Regulatory Affairs Specialist II
Net2source, Chaska, Minnesota, United States, 55318
Net2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting company across the USA and we are hiring "Job Title " for one of our clients. We offer a wide gamut of consulting solutions customized to our 450+ clients ranging from Fortune 500/1000 to Start-ups across various verticals like Technology, Financial Services, Healthcare, Life Sciences, Oil & Gas, Energy, Retail, Telecom, Utilities, Technology, Manufacturing, the Internet, and Engineering.Please find below mentioned job details:Job Title: Regulatory Affairs Specialist IILocation: Chaska MN 55318Duration:12+ Month ContractMon-Fri 8 to 5/Flex 7:30 AM to 4:30 PMPOSITION SUMMARYThe Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs. Support the IA business units in meeting global registration requirements. As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our products, processes and procedures, advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints. Ensures timely preparation of organized and scientifically valid reports both internally and externally - Coordinates and manages the post-market regulatory reporting and compliance activities in accordance with Company procedures and regulatory requirements. - - Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling regulatory compliance obligations, and maintaining regulatory intelligence. - Prepares and maintains regulatory licenses, reports, and listings.Minimum qualifications:
3-5 YEARS EXPERIENCE IN DIAGNOSTIC REGULATORY AFFAIRS IVD / IVDR KNOWLEDGE, GLOBAL REGISTRATIONS (EU, CANADA, BRAZIL, LATIN AMERICA, ASIA Client . Bachelors degree in sciences, engineering, or technical field and 5 years of relevant experience or a Masters degree and 2 years of relevant experience or PhD and 1 year of relevant experience for SENIOR level.Professionals with technical skills stated below but less relevant experience may be considered for ASSOCIATE level Regulatory Affairs. - Work experience with medical devices, pharmaceuticals and/or in-vitro diagnostic fields. Previous regulatory experience desirable. - Ability to prioritize assigned work. - Ability to learn regulatory procedures. - Ability to communicate accurately with internal and external contacts. - Ability to work with team members to resolve problems and achieve goals. - Experience with LEAN principles desirable. - Experience with risk management (FMEA/HHA) desirable. - RAC desired.3 skills required for this position
1. Regulatory experience in Medical Device Industry i.e Post Market Activities; field actions (recalls), supporting international registrations, and design change evaluations. 2. Communication skills/Team Player to establish strong working relationships with cross-functional teams. 3. Critical thinking and problem-solvingAbout Net2Source, Inc.Net2Source is a total talent management solutions company with its presence in 50+ countries. Our creative solution service offerings aim at becoming your one stop destination for hiring talent needs globally.Want to read more about Net2Source? Visit us at www.net2source.comEqual Employment Opportunity CommissionThe United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.Fast Facts about Net2Source:Founded in 2007100% Minority Owned, Debt Free, Private4100+ consultants globally2550 consultants placed in the US750+ team of in-house staffing team30+ sales offices in the US, and 50+ Offices globallyOperations in 20 countries (US, Canada, Mexico, APAC, UK, UAE, Europe, , Europe, Latin America, Japan, Australia)Awards and Accolades:1. 2020 Fast 100 Asian American Businesses by the US Pan Asian American Chamber of Commerce Education Foundation (USPAACC 2019)2. 2019 & 2018 Ranked 21st Fastest Growing Staffing Company in USA by Staffing industry Analysts3. 2019 & 2018 Fastest 50 by NJ Biz (Ranked (9th and 27th ).4. 2019 Top 100 Fastest companies to grow in Dallas by Dallas Business Journal.5. INC 5000 Fastest growing for 8 consecutive years in a row.6. America's Most Honored Businesses (Top 10%)7. 2019 Dallas Top 100 by Dallas Business Journal8. 2019 Proven Supplier of the Year by Workforce Logiq9. 2019 Spirit of Alliance Award by Agile110. 2018 Best of the Best Platinum Award by Agile111. 2018 TechServe Alliance Excellence Awards Winner12. 2017 Best of the Best Gold Award by Agile1(Act1 Group)
3-5 YEARS EXPERIENCE IN DIAGNOSTIC REGULATORY AFFAIRS IVD / IVDR KNOWLEDGE, GLOBAL REGISTRATIONS (EU, CANADA, BRAZIL, LATIN AMERICA, ASIA Client . Bachelors degree in sciences, engineering, or technical field and 5 years of relevant experience or a Masters degree and 2 years of relevant experience or PhD and 1 year of relevant experience for SENIOR level.Professionals with technical skills stated below but less relevant experience may be considered for ASSOCIATE level Regulatory Affairs. - Work experience with medical devices, pharmaceuticals and/or in-vitro diagnostic fields. Previous regulatory experience desirable. - Ability to prioritize assigned work. - Ability to learn regulatory procedures. - Ability to communicate accurately with internal and external contacts. - Ability to work with team members to resolve problems and achieve goals. - Experience with LEAN principles desirable. - Experience with risk management (FMEA/HHA) desirable. - RAC desired.3 skills required for this position
1. Regulatory experience in Medical Device Industry i.e Post Market Activities; field actions (recalls), supporting international registrations, and design change evaluations. 2. Communication skills/Team Player to establish strong working relationships with cross-functional teams. 3. Critical thinking and problem-solvingAbout Net2Source, Inc.Net2Source is a total talent management solutions company with its presence in 50+ countries. Our creative solution service offerings aim at becoming your one stop destination for hiring talent needs globally.Want to read more about Net2Source? Visit us at www.net2source.comEqual Employment Opportunity CommissionThe United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.Fast Facts about Net2Source:Founded in 2007100% Minority Owned, Debt Free, Private4100+ consultants globally2550 consultants placed in the US750+ team of in-house staffing team30+ sales offices in the US, and 50+ Offices globallyOperations in 20 countries (US, Canada, Mexico, APAC, UK, UAE, Europe, , Europe, Latin America, Japan, Australia)Awards and Accolades:1. 2020 Fast 100 Asian American Businesses by the US Pan Asian American Chamber of Commerce Education Foundation (USPAACC 2019)2. 2019 & 2018 Ranked 21st Fastest Growing Staffing Company in USA by Staffing industry Analysts3. 2019 & 2018 Fastest 50 by NJ Biz (Ranked (9th and 27th ).4. 2019 Top 100 Fastest companies to grow in Dallas by Dallas Business Journal.5. INC 5000 Fastest growing for 8 consecutive years in a row.6. America's Most Honored Businesses (Top 10%)7. 2019 Dallas Top 100 by Dallas Business Journal8. 2019 Proven Supplier of the Year by Workforce Logiq9. 2019 Spirit of Alliance Award by Agile110. 2018 Best of the Best Platinum Award by Agile111. 2018 TechServe Alliance Excellence Awards Winner12. 2017 Best of the Best Gold Award by Agile1(Act1 Group)