DEXCOM, INC.

Manager, Regulatory Affairs

A-22252-19064 H-1B 2023 Certified

薪资水平

$176,550

签证类型

H-1B

职位

Manager, Regulatory Affairs

雇员国籍

INDIA

毕业院校

NORTHEASTERN UNIVERSITY

案例相关公司相关 HR相关律师相关职业相关雇员信息

案例相关

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数据公布年 2023

申请编号 A-22252-19064

申请状态 Certified

收件日期 2022-10-10

通过日期 2023-08-24

曾备案（Y/N） N

原备案日期 -

原SWA申请编号 -

是否为紧缺/短缺职位 N

公司相关

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雇主公司名 DEXCOM, INC.

雇主地址-第一行 6340 SEQUENCE DRIVE

雇主地址-第二行 -

雇主城市 SAN DIEGO

申请州 -

雇主所在州/省 CALIFORNIA

雇主所在国 UNITED STATES OF AMERICA

雇主邮编 92121

雇主电话 (858) 875-9520

雇主分机号 -

雇员总数 4500

雇主经营年限 1999

北美行业代码 334510

雇员雇主所有权及家庭联系 N

HR相关

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雇主联系人 Melia Nicole Kunde

雇主联系人地址 6310 Sequence Drive

雇主联系人地址 -

雇主联系人城市 San Diego

雇主联系人州/省 CALIFORNIA

雇主联系人国 UNITED STATES OF AMERICA

雇主联系人邮编 92121

雇主联系人电话 (858) 875-9761

雇主联系人邮件 nicole.kunde@dexcom.com

律师相关

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代理人/律师姓名 Diana V Coker

代理人/律师公司名称 Larrabee Albi Coker LLP

代理人/律师电话 (858) 642-0420

代理人/律师分机号 -

代理人/律师地址 Larrabee Albi Coker LLP

代理人/律师地址 P.O. Box 919016

代理人/律师城市 San Diego

代理人/律师州/省 CALIFORNIA

代理人/律师国 UNITED STATES OF AMERICA

代理人/律师邮编 -

代理人/律师邮箱 diana@larrabee.com

职业相关

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现行工资跟踪号 P10021295663298

职业代码 11-9199.01

职业名称 Regulatory Affairs Managers

技能等级 Level IV

现行工资 176550

现行工资周期 Year

现行工资信息实体 OES

其他现行工资信息来源 -

现行工资确定日期 2022-04-26

现行工资失效日期 2022-07-25

起薪点 176550

工资最高点 -

工资支付周期 Year

工作地址 Remote employment, reporting to

工作地址 6340 Sequence Drive

工作城市 San Diego

工作州 CALIFORNIA

工作邮编 92121

工作职位 Manager, Regulatory Affairs

最低学历 Bachelor's

其他教育学历 -

对应专业 See H.14

所需培训 N

培训时长 -

所需培训领域 -

前置经验 Y

经验时长（月） 96

替代领域学历 Y

替代专业 See H.4B

可替代教育及经验组合 N

所需教育层级 -

其他可替代教育层级 -

认可经验年限 -

境外教育背景 Y

可替代职业 Y

可替代职业时长（月） 96

可替代职业名称 Pharmaceutical Scientist or Pharmaceutical Engineer

是否为正常职业要求 N

是否需要外语 N

特殊技能 H.1 and H.2 This is a remote employment from anywhere in the United States reporting to Dexcom, Inc.s office at 6340 Sequence Drive, San Diego, CA 92121. Employee telecommutes and may report to the office once per quarter.br br H.4 and H.4B Bachelors degree or equivalent in Regulatory Science, Pharmaceutical Science, Chemistry, Chemical Engineering, Mechanical Engineering, Software Engineering, or a related academic field.br br H.6A 8 years of progressive experience in the job offered defined by employer as Regulatory Affairs. 8 years of experience must include 2 years of experience in a management or lead role.br br H.10A and H.10B 8 years of progressive experience in the occupation of Pharmaceutical Scientist or Pharmaceutical Engineer. 8 years of experience must include 2 years of experience in a management or lead role.br br H.12 Job requirements are normal for the employer due to the complexity of job duties associated with this position. Employer answered no to Question H.12 based on SVP analysis.br br Work experience to include 1 6 years of experience in the U.S. and Outside of U.S. premarket and postmarket medical device regulatory requirements. 2 6 years of experience with the medical device or pharmaceutical industry in the U.S., EMEA, or LATAM regions. 3 Managing crossfunctional projects. 4 Developing FDA and EU MDD Medical Device Directive or EU MDR Medical Device Regulation submissions for medical devices. 5 Providing regulatory strategy, regulatory guidance and change assessment for medical devices. 6 Preparing written reports and presentations on regulatory matters for management and customers, including medical professionals. 7 Making presentations to project management teams for regulatory plans and status updates. 8 Reviewing and signing medical product design and change documentation, test protocols and reports, product labeling, instructions for use, and manufacturing procedures documentation. 9 Participating in risk mitigation and control measure activities for medical devices. 10 Reviewing design change control documents, product recall documentation, field action documentation, validation reports, risk management reports, nonconforming material reports, corrective and preventive action plans and reports, and post market product surveillance reports. 11 Preparing domestic and international medical product submissions to regulatory agencies.br br Any and all experience may be gained concurrently.br br Position requires 10 domestic travel and 5 international travel; expenses paid by employer.br br Employer requires background checks.

职业组合 N

是否提供给申请人 Y

是否在地工作 N

是否为住家家政 N

是否签订合同 -

是否为专业职业 Y

是否为大学老师 N

竞争性招聘 -

基础招聘流程 -

竞争性招聘日期 -

广告投放期刊名 -

补充招聘信息 -

SWA订单开始日期 2022-06-07

SWA订单结束日期 2022-08-19

周日见报 Y

首次见报刊名 The San Diego UnionTribune

首次见报日期 2022-06-12

二次见报刊名 The San Diego UnionTribune

二次刊登种类 Newspaper

二次刊登日期 2022-06-19

招聘会起始日期 -

招聘会截止日期 -

校招起始日期 -

校招截止日期 -

雇主网站起始日期 -

雇主网站截止日期 -

专业机构起始日期 -

专业机构截止日期 -

招聘网站起始日期 2022-06-12

招聘网站截止日期 2022-06-20

私营就业起始日期 -

私营就业截止日期 -

内推起始日期 -

内推结束日期 -

校办推荐起始日期 2022-06-16

校办推荐截止日期 2022-06-23

本地报纸起始日期 2022-06-17

本地报纸截止日期 2022-06-17

电台/TV广告起始日期 -

电视/TV广告截止日期 -

聘方收费 N

收费细节 -

通知谈判代表 N/A

备案通知张贴 Y

雇主裁员 N

通知美国工人 -

外籍工人国籍 INDIA

工人出生国籍 INDIA

工人签证状态 H-1B

雇员信息

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教育背景 Master's

其他教育背景 -

专业背景 REGULATORY AFFAIRS

教育完成年份 2011

教育机构名 NORTHEASTERN UNIVERSITY

教育机构地址1 360 HUNTINGTON AVENUE

教育机构地址2 -

工人受教城市 BOSTON

工人受教州 MA

工人受教国 UNITED STATES OF AMERICA

工人受教邮编 2115

是否完成培训 N/A

所需经验 Y

教育和经验 N/A

外国工人经验 N

雇主经验 N

雇主教育报销 N

受雇于请愿雇主 Y

雇主申请完成 N

准备者姓名 Diana V Coker

准备者职位 Partner Attorney at Law

准备者邮件 diana@larrabee.com

雇主声明签字者姓名 Melia Nicole Kunde

雇主声明签署者职位 Sr. Employee Relations Compliance Specialist