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Regulatory Affairs Professional 2 (QM - QM - REGAF - PR08)

In Massachusetts / United States

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Regulatory Affairs Professional 2 (QM - QM - REGAF - PR08)   

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JOB TITLE:

Regulatory Affairs Professional 2 (QM - QM - REGAF - PR08)

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Norwood Massachusetts / United States

JOB DESCRIPTION:

Description:

Key Responsibilities:

Represents Regulatory Affairs on Post-Market RA Team for the Point-of-Care Business Area.
• Support International Product Registrations.
• Completes regulatory documentation for CE Marking IVD medical devices (Technical File updates, Declaration of Conformity etc.)
• Requests Certificates to Foreign Governments, Free Sale Certificates.
• Coordinates and tracks notarization and legalization of regulatory documents.
• Notifies countries of product changes and collects registration information for product teams.
• Interacts closely with multiple functions, including Manufacturing, R&D, Marketing, Logistics, Labeling etc.
• Completes the review of promotional material and device labeling for regulatory compliance.

Required Knowledge/Skills, Education, and Experience
• Required Bachelor’s degree (preferred in life sciences)
• Required industry experience: 2-5 years
• No travel
• Demonstrated attention to detail, able to manage and track multiple requests at once.
Preferred Knowledge/Skills, Education, and Experience
• Prefer experience in medical device industry and with technical design documentation (2 -5 years)

Education:
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.

Position Details

POSTED:

Jun 23, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S162048615557310518

LOCATION:

Massachusetts / United States

CITY:

Norwood

Job Origin:

Jobsrus_organic_feed

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Regulatory Affairs Professional 2 (QM - QM - REGAF - PR08)    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Description:

Key Responsibilities:

Represents Regulatory Affairs on Post-Market RA Team for the Point-of-Care Business Area.
• Support International Product Registrations.
• Completes regulatory documentation for CE Marking IVD medical devices (Technical File updates, Declaration of Conformity etc.)
• Requests Certificates to Foreign Governments, Free Sale Certificates.
• Coordinates and tracks notarization and legalization of regulatory documents.
• Notifies countries of product changes and collects registration information for product teams.
• Interacts closely with multiple functions, including Manufacturing, R&D, Marketing, Logistics, Labeling etc.
• Completes the review of promotional material and device labeling for regulatory compliance.

Required Knowledge/Skills, Education, and Experience
• Required Bachelor’s degree (preferred in life sciences)
• Required industry experience: 2-5 years
• No travel
• Demonstrated attention to detail, able to manage and track multiple requests at once.
Preferred Knowledge/Skills, Education, and Experience
• Prefer experience in medical device industry and with technical design documentation (2 -5 years)

Education:
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.


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