Michaela Ragoonath
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Michaela Ragoonath Email & Phone Number

Senior Regulatory Affairs Specialist (Medical Devices) at STEMCELL Technologies
Location: Vancouver, British Columbia, Canada 4 work roles 2 schools
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Current company
Role
Senior Regulatory Affairs Specialist (Medical Devices)
Location
Vancouver, British Columbia, Canada
Company size

Who is Michaela Ragoonath? Overview

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Quick answer

Michaela Ragoonath is listed as Senior Regulatory Affairs Specialist (Medical Devices) at STEMCELL Technologies, a with 1172 employees, based in Vancouver, British Columbia, Canada. AeroLeads shows a matched LinkedIn profile for Michaela Ragoonath.

Michaela Ragoonath previously worked as Systems & Quality Developer at Libang Surgical Technologies and Biomedical Engineer at Led Dental. Michaela Ragoonath holds Associate Certificate, Project Management from British Columbia Institute Of Technology.

Company email context

Email format at STEMCELL Technologies

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STEMCELL Technologies

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Profile bio

About Michaela Ragoonath

With more than 7 years of engineering experience in medical device development and manufacturing, I have worked with both hardware and software products in pre-market and post-market stages. I am passionate about applying quality management systems and market regulations to the development process, ensuring regulatory compliance, and successfully transitioning products from concept to commercial. My skill set is diverse and includes project management, market research, and preparation of funding applications, proposals, and technical submissions.

Listed skills include Project Management, Marketing, Technical Writing, Technical Support, and 4 others.

Current workplace

Michaela Ragoonath's current company

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STEMCELL Technologies
Stemcell Technologies
Senior Regulatory Affairs Specialist (Medical Devices)
vancouver, british columbia, canada
Website
Employees
1172
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4 roles

Michaela Ragoonath work experience

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

Senior Regulatory Affairs Specialist (Medical Devices)

Current

Vancouver, British Columbia, Canada

Sep 2023 - Present

Systems & Quality Developer

Vancouver, British Columbia, Canada

- Collaborated with senior management to understand business development timelines and make recommendations related to change management and implementation of formal engineering product development procedures and quality system procedures. - Developed, implemented, and maintained a requirements management solution to support design control and demonstrate traceability of design inputs. Performed requirements engineering as required. - Led risk management and usability engineering activities throughout the product development lifecycle as prescribed by ISO 14971 & IEC 62366. - Participated in design reviews to ensure that both quality system and external standards were adequately incorporated during product development. - Developed engineering and quality system procedures. Trained employees on procedures related to their roles and maintain records. Generated SOP’s and test documentation.

Jan 2021 - Aug 2023

Biomedical Engineer

Vancouver, British Columbia, Canada

- Managed the Tuxedo Intraoral X-Ray Sensor product line including leading product development and manufacturing engineering as well as managing all quality and regulatory activities according to ISO 13485. - Conducted operational activities including post-market surveillance, leading and developing the Tuxedo Returns pipeline, assisting with supply chain activities such as vendor management, procurement and fulfilment as well as monitoring distributor activity.- Performed engineering activities related to new product development across all product lines such as conducting and coordinating market research, working with stakeholders to develop requirements and specifications, participating in risk analysis activities and leading or participating in design verification and validation activities. - Supported LED Dental Inc. and subsidiaries with technical submissions and project proposal bids as well as meeting and adhering to US Federal contractual obligations. - Participated in Senior Management Reviews as well as Internal and External Audits.

Sep 2017 - Dec 2020

Production Services Technician (Sr.)

Vancouver, British Columbia, Canada

- Managed and maintained all production-related data including ingesting media from vendors and clients to conform to facility standards for internal use. - Provided professional and reliable departmental technical expertise to digital artists and productions teams for tasks including resource management as well as implementing and enforcing standard naming conventions and work environments. - Processed and distributed deliverable media for daily and critical client review, prepared data for global exchange via secure mediums in addition to ensuring consistent data transfer between studio facilities. - Monitored, booked and provided initial troubleshooting to all renders in the queue, ensuring their successful completion to support the production time-sensitive pipeline. - Worked with the resource managers of the department to monitor critical servers, network and file server loads throughout the duration of the movie including after wrapping to safely archive and remove data.

May 2015 - Aug 2016
Team & coworkers

Colleagues at STEMCELL Technologies

Other employees you can reach at stemcell.com. View company contacts for 1172 employees →

2 education records

Michaela Ragoonath education

Bachelor Of Applied Science - Basc, Electrical Engineering, Biomedical Engineering Specialization

Activities and Societies: UBC Thunderbots (2014 - 2017)

FAQ

Frequently asked questions about Michaela Ragoonath

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

What company does Michaela Ragoonath work for?

Michaela Ragoonath works for STEMCELL Technologies.

What is Michaela Ragoonath's role at STEMCELL Technologies?

Michaela Ragoonath is listed as Senior Regulatory Affairs Specialist (Medical Devices) at STEMCELL Technologies.

Where is Michaela Ragoonath based?

Michaela Ragoonath is based in Vancouver, British Columbia, Canada while working with STEMCELL Technologies.

What companies has Michaela Ragoonath worked for?

Michaela Ragoonath has worked for Stemcell Technologies, Libang Surgical Technologies, Led Dental, and Sony Pictures Imageworks.

Who are Michaela Ragoonath's colleagues at STEMCELL Technologies?

Michaela Ragoonath's colleagues at STEMCELL Technologies include Sara Dal-Santo, Belle Lin Straley, Vernique Tipon, Taba Dash, and (Sunny)Yang Miao.

How can I contact Michaela Ragoonath?

You can use AeroLeads to view verified contact signals for Michaela Ragoonath at STEMCELL Technologies, including work email, phone, and LinkedIn data when available.

What schools did Michaela Ragoonath attend?

Michaela Ragoonath holds Associate Certificate, Project Management from British Columbia Institute Of Technology.

What skills is Michaela Ragoonath known for?

Michaela Ragoonath is listed with skills including Project Management, Marketing, Technical Writing, Technical Support, Engineering, Quality System, Product Development, and Regulatory Affairs.

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