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QA Specialist I

In Texas / United States

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QA Specialist I   

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JOB TITLE:

QA Specialist I

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Ontario Texas / United States

JOB DESCRIPTION:

Description
Bachelor’s degree in scientific or healthcare-related field
Education in Regulatory/Quality is preferred
Willingness to challenge existing systems/practices in order to improve them.
Effective written and oral communication, interpersonal skills, facilitation and influencing skills with an ability to work effectively with internal and external stakeholders.

Minimum of 2 year experience working in a Quality and Regulatory role in the medical device industry


Ensures timely reports of post market vigilance activities such as adverse events, safety events and recalls to regulatory requirements. Write and submit medical device reports, consumer incident reports and regulatory recalls. Ensures all post market regulatory requirements are met. Communicates customer feedback investigations to the customer.
Ensure timely reports of pre-market activities including consultation of license maintenance for current or new product/solution licensing and the review/approval of labelling and marketing communication as requested. If applicable, ensure timely reporting of any post market information requests. Align regulatory deliverables with sales and marketing.
• Work with a variety of diverse persons to facilitate reportable device events in accordance with written procedures and global reporting requirements.
• Prepare and submit Consumer Incident Reports to Health Canada as required and maintain all records
• Prepare and submit Mandatory Problem Reports to Health Canada as required and maintain all records.
• Determine reportability decision for recalls in Canada and prepare and submit recall report (Health Systems, Personal Health)
• Monitor and improve tracking/control systems for medical device reporting.
• Investigate and prepare responses to address Competent Authority inquiries and provide follow-up.
• Manage and execute product field actions and product holds when quality issues are identified.
• Ensure client Medical Device Establishment License (MDEL) is maintained in good standing with Health Canada.
• Participate in the coordination of external government audits and client Global quality audits.
• Provide regular reports of quality management system metrics for post-market activities.
• Manage radiation servicing notifications.
• Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements and standards (not in the field)
• Review licensing submission contents to ensure information aligns with Health Canada submission requirements.
• Coordinate regulatory submissions for product/solution licensing as requested.
• Coordinate timely reporting of any post market information requests (generally at the BIU)
• Understands and applies regulatory requirements and their impacts in reviewing licensing submissions
• Supports and encourages a collaborative, open and team based culture across
organization and the larger Q&R organization
• Demonstrate knowledge of Health Canada regulatory and quality requirements and utilizes depth and breadth of experience to assess regulatory changes, risk and business impact.
• Oversee the product hold in alignment with Corporate policies and procedures.
• Provide ongoing guidance and direction to operations and other business functions regarding regulatory and quality matters.

Position Details

POSTED:

Apr 20, 2022

EMPLOYMENT:

INDUSTRY:

Health Care

SNAPRECRUIT ID:

S1643918409429813

LOCATION:

Texas / United States

CITY:

Ontario

Job Origin:

Jobsrus_organic_feed

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

QA Specialist I    Apply

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Description
Bachelor’s degree in scientific or healthcare-related field
Education in Regulatory/Quality is preferred
Willingness to challenge existing systems/practices in order to improve them.
Effective written and oral communication, interpersonal skills, facilitation and influencing skills with an ability to work effectively with internal and external stakeholders.

Minimum of 2 year experience working in a Quality and Regulatory role in the medical device industry


Ensures timely reports of post market vigilance activities such as adverse events, safety events and recalls to regulatory requirements. Write and submit medical device reports, consumer incident reports and regulatory recalls. Ensures all post market regulatory requirements are met. Communicates customer feedback investigations to the customer.
Ensure timely reports of pre-market activities including consultation of license maintenance for current or new product/solution licensing and the review/approval of labelling and marketing communication as requested. If applicable, ensure timely reporting of any post market information requests. Align regulatory deliverables with sales and marketing.
• Work with a variety of diverse persons to facilitate reportable device events in accordance with written procedures and global reporting requirements.
• Prepare and submit Consumer Incident Reports to Health Canada as required and maintain all records
• Prepare and submit Mandatory Problem Reports to Health Canada as required and maintain all records.
• Determine reportability decision for recalls in Canada and prepare and submit recall report (Health Systems, Personal Health)
• Monitor and improve tracking/control systems for medical device reporting.
• Investigate and prepare responses to address Competent Authority inquiries and provide follow-up.
• Manage and execute product field actions and product holds when quality issues are identified.
• Ensure client Medical Device Establishment License (MDEL) is maintained in good standing with Health Canada.
• Participate in the coordination of external government audits and client Global quality audits.
• Provide regular reports of quality management system metrics for post-market activities.
• Manage radiation servicing notifications.
• Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements and standards (not in the field)
• Review licensing submission contents to ensure information aligns with Health Canada submission requirements.
• Coordinate regulatory submissions for product/solution licensing as requested.
• Coordinate timely reporting of any post market information requests (generally at the BIU)
• Understands and applies regulatory requirements and their impacts in reviewing licensing submissions
• Supports and encourages a collaborative, open and team based culture across
organization and the larger Q&R organization
• Demonstrate knowledge of Health Canada regulatory and quality requirements and utilizes depth and breadth of experience to assess regulatory changes, risk and business impact.
• Oversee the product hold in alignment with Corporate policies and procedures.
• Provide ongoing guidance and direction to operations and other business functions regarding regulatory and quality matters.


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