Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr)
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Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) Email & Phone Number

Regulatory and Clinical Director at Sinocare Meditech Inc.
Location: Markham, Ontario, Canada 6 work roles 3 schools
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Current company
Sinocare Meditech Inc.
Role
Regulatory and Clinical Director
Location
Markham, Ontario, Canada
Company size
9 employees

Who is Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr)? Overview

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Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) is listed as Regulatory and Clinical Director at Sinocare Meditech Inc., a company with 9 employees, based in Markham, Ontario, Canada. AeroLeads shows a matched LinkedIn profile for Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr).

Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) previously worked as Regulatory and Clinical Affairs Director at Sinocare Meditech Inc. and RA/QA Director at Fosun Pharma 复星医药. Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) holds Master’S Degree, Biology from The University Of British Columbia.

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Email format at Sinocare Meditech Inc.

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Sinocare Meditech Inc.

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Profile bio

About Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr)

Strong technical and regulatory affairs background with a combination of Engineering (BSE) and Science (M.Sc). 15+ years of extensive hands-on global medical device RA experience in:-de novo application, 510k, annual reports, establishment renewal-MDR New Design Dossier, Design Dossier Amendment/Annual Update-Canadian License Amendment, Fax Back, License and Establishment Renewal-Chinese Class II&III New Product Application, type testing follow-up, CER, clinical trials, etc. -EMEA, Latin America, other Asia (New Registration, Change Application, FSC requests, etc.)

Listed skills include Quality Management, Recalls, Regulations, Clinical Trials, and 28 others.

Current workplace

Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr)'s current company

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Sinocare Meditech Inc.
Sinocare Meditech Inc.
Regulatory and Clinical Director
Markham, ON, CA
Website
sinocare.com
Employees
9
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Company profile
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6 roles

Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) work experience

A career timeline built from the work history available for this profile.

Regulatory And Clinical Affairs Director

Current
Sinocare Meditech Inc.

- Lead regulatory submissions including 510(k) premarket notifications and Q-subs for US FDA. - Design and execute product clinical validation studies in United States. - Formulated comprehensive regulatory and clinical strategies for all submissions in China, encompassing regulatory pathways and clinical evaluation plans. Accurately estimated registration.

Jan 2021 - Present

Ra/Qa Director

Fosun Pharma 复星医药

Shanghai, Shanghai, CN

  • Determine and document appropriate regulatory strategy for proposed new AI/ML based SaMD products. Support design control activities.
  • Lead regulatory submissions including NMPA Class III, EU MDR and 510(k) premarket notifications Q-subs for US FDA.
  • Design and execute product clinical validation studies in United States.
  • Lead new product introduction projects that support China NMPA submissions
Jan 2020 - Dec 2020

Regulatory Compliance Manager

Merge Healthcare, An Ibm Company

Chicago, IL, US

-Develop regulatory strategy in support of AI/ML-Based device clearances globally, experienced in US FDA de novo, 510(k), Canadian Licensing, EU Technical File, Australia TGA and CFDA registration.-Acts as liaison for UL/CSA/INTERTEK/SGS/TUV inspection/ follow-up activities.-Geographic Responsibility – US, Canada, EU, Australia, Brazil, China, Japan.

Jan 2017 - Dec 2019

Sr. Regulatory Affairs Specialist

Sciex

Framingham, MA, US

- Prepare and maintain annual reports and renewals, such as CFDA re-registration, US FDA Annual Establishment renewal, US FDA Annual Laser Reports, EU Medical Device annual review of post-market surveillance and clinical data.- Author to DEN170019. Key contributor to EU IVDD regulatory approval for API 3200MD, 4500MD and QTRAP® LC/MS/MS systems

Jun 2014 - Jan 2017

Regulatory Affairs Project Manager

Procter & Gamble

Cincinnati, Ohio, US

- Develop regulatory strategies to secure rapid approvals with optimum labelling with Health Canada for OTC Drug, Natural Health Products, Cosmetic Product and Medical Devices.- Obtained Health Canada approval of Class II device- Provide global regulatory impact assessments to US, EU, CA, and APAC

Jan 2013 - Jun 2014
Team & coworkers

Colleagues at Sinocare Meditech Inc.

Other employees you can reach at sinocare.com. View company contacts for 9 employees →

杨 杨如树 杨如树 Colleague at Sinocare Meditech Inc. Changsha, Hunan, China, China View → 何 何章国 何章国 Colleague at Sinocare Meditech Inc. Hefei, Anhui, China, China View → AP Aimee Peng Aimee Peng Colleague at Sinocare Meditech Inc. Shenzhen, Guangdong, China, China View → 彭 彭宇凤 彭宇凤 Colleague at Sinocare Meditech Inc. Changsha, Hunan, China, China View → 欧 欧阳柏伸 欧阳柏伸 Colleague at Sinocare Meditech Inc. Changsha, Hunan, China, China View → 杜 杜飞虎 杜飞虎 Colleague at Sinocare Meditech Inc. Chengdu, Sichuan, China, China View → 马 马祥宇 马祥宇 Colleague at Sinocare Meditech Inc. China, China View → 周 周学良 周学良 Colleague at Sinocare Meditech Inc. Heilongjiang, China, China View → XL Xiangnan Lei Xiangnan Lei Colleague at Sinocare Meditech Inc. Changsha, Hunan, China, China View → 陈 陈俊材 陈俊材 Colleague at Sinocare Meditech Inc. Jiangxi, China, China View →
3 education records

Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) education

Master’S Degree, Biology

The University Of British Columbia

Bachelor Of Science - Hbasc, Biomedical/Medical Engineering

China Agricultural University

Pharmaceutical Regulatory Affairs And Quality Operations

Seneca Polytechnic
FAQ

Frequently asked questions about Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr)

Quick answers generated from the profile data available on this page.

What company does Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) work for?

Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) works for Sinocare Meditech Inc..

What is Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr)'s role at Sinocare Meditech Inc.?

Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) is listed as Regulatory and Clinical Director at Sinocare Meditech Inc..

Where is Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) based?

Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) is based in Markham, Ontario, Canada while working with Sinocare Meditech Inc..

What companies has Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) worked for?

Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) has worked for Sinocare Meditech Inc., Fosun Pharma 复星医药, Merge Healthcare, An Ibm Company, Sciex, and Procter & Gamble.

Who are Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr)'s colleagues at Sinocare Meditech Inc.?

Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr)'s colleagues at Sinocare Meditech Inc. include 杨如树, 何章国, Aimee Peng, 彭宇凤, and 欧阳柏伸.

How can I contact Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr)?

You can use AeroLeads to view verified contact signals for Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) at Sinocare Meditech Inc., including work email, phone, and LinkedIn data when available.

What schools did Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) attend?

Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) holds Master’S Degree, Biology from The University Of British Columbia.

What skills is Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) known for?

Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) is listed with skills including Quality Management, Recalls, Regulations, Clinical Trials, International Trade, Natural Health Products, Ectd, and Gmp.

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