Regulatory/Quality Intern
Mississauga, ON, Canada
Internship
Student (College)
About Us
At Myant, we are creating the world’s first expressive and continuous digital presence platform, enabled by integrating technology directly into clothing and augmented by other devices, wearables, and IOT. We see the evolution of society where every member gets to participate from anywhere and anytime through a whole-body experience, mostly in a passive or ambient manner to foster ubiquitous accessibility. Humans have a fundamental desire and need to be connected to our environment, family, community, and technology. This level of connection will create a paradigm shift in the way we deal with each other, especially from afar, allowing for more meaningful relationships, and more in-depth representation of ourselves.
The need for this type of connection is not new. There are many companies working on ways to connect humans in singularity with technology, however most of these technologies are based on devices that are often used in episodical ways hence, leading to poor adoption or reliability. In general, innovation and technology have delivered significant benefits for many members of society. However, there are those who are left behind, namely the very young, the marginalized, the old and the sick. The challenge of inclusion for those left behind requires us to move beyond device focused strategies, towards an interface that we use naturally, every day. We believe that textile is that primary interface, used in clothing, coverings, carpeting and more, we wear and are surrounded by textiles universally, always.
Such an interface could fuse data with other devices that we use periodically and data with other IoTs in the environment. People could then leverage their physical presence over their digital presence to communicate and share personal wellbeing. This could unlock healthcare that is proactive and preventative, social connectedness that is more profound, enable care distribution models to be seamless and on demand, better fitness insights, safer working environments and more.
The vision for SKIIN -our first consumer-facing brand- is to enhance human ability through connected clothing and textiles. Skiin is in beta-phase market launch and has been recently granted Health Canada medical device license and submitted to FDA for regulatory approval in the US market. The sensors and actuators embedded within our apparel create your Digital Identity, which will be consumed by those who matter to you - your family members, physicians, trainers, other IoT devices - without you consciously having to think about it. The line between the digital and physical world is becoming increasingly blurry and we believe textile is the next medium to bridge that gap.
We are a multi-disciplinary technology team solving big challenges at the intersection of electronics, deep tech., software, design, advanced manufacturing, and data science.
What we offer at Myant:
Role
This internship provides an excellent opportunity for students or recent graduates to
gain hands-on experience in the medical device industry, working alongside
experienced professionals to ensure compliance with regulatory and quality standards.
Responsibilities
Regulatory Affairs Support:
Qualifications:
At Myant, we are creating the world’s first expressive and continuous digital presence platform, enabled by integrating technology directly into clothing and augmented by other devices, wearables, and IOT. We see the evolution of society where every member gets to participate from anywhere and anytime through a whole-body experience, mostly in a passive or ambient manner to foster ubiquitous accessibility. Humans have a fundamental desire and need to be connected to our environment, family, community, and technology. This level of connection will create a paradigm shift in the way we deal with each other, especially from afar, allowing for more meaningful relationships, and more in-depth representation of ourselves.
The need for this type of connection is not new. There are many companies working on ways to connect humans in singularity with technology, however most of these technologies are based on devices that are often used in episodical ways hence, leading to poor adoption or reliability. In general, innovation and technology have delivered significant benefits for many members of society. However, there are those who are left behind, namely the very young, the marginalized, the old and the sick. The challenge of inclusion for those left behind requires us to move beyond device focused strategies, towards an interface that we use naturally, every day. We believe that textile is that primary interface, used in clothing, coverings, carpeting and more, we wear and are surrounded by textiles universally, always.
Such an interface could fuse data with other devices that we use periodically and data with other IoTs in the environment. People could then leverage their physical presence over their digital presence to communicate and share personal wellbeing. This could unlock healthcare that is proactive and preventative, social connectedness that is more profound, enable care distribution models to be seamless and on demand, better fitness insights, safer working environments and more.
The vision for SKIIN -our first consumer-facing brand- is to enhance human ability through connected clothing and textiles. Skiin is in beta-phase market launch and has been recently granted Health Canada medical device license and submitted to FDA for regulatory approval in the US market. The sensors and actuators embedded within our apparel create your Digital Identity, which will be consumed by those who matter to you - your family members, physicians, trainers, other IoT devices - without you consciously having to think about it. The line between the digital and physical world is becoming increasingly blurry and we believe textile is the next medium to bridge that gap.
We are a multi-disciplinary technology team solving big challenges at the intersection of electronics, deep tech., software, design, advanced manufacturing, and data science.
What we offer at Myant:
- Employee stock options
- Paid Sick Days and Floating Days
- Group Health Insurance Plan
- RRSP matching Plan
- Corporate Events
- Exposure working in one of the most innovative and forward-thinking tech companies.
Role
This internship provides an excellent opportunity for students or recent graduates to
gain hands-on experience in the medical device industry, working alongside
experienced professionals to ensure compliance with regulatory and quality standards.
Responsibilities
Regulatory Affairs Support:
- Assist in the preparation and submission of regulatory documents, including premarket notifications (510(k)s), technical files, and other regulatory submissions.
- Conduct research on regulatory requirements and guidelines to support product development and regulatory strategies.
- Maintain and update regulatory databases and tracking systems.
- Help prepare for regulatory agency meetings and inspections by organizing documentation and drafting responses to regulatory inquiries.
- Assist in maintaining the Quality Management System (QMS) in compliance with ISO 13485 and other relevant standards.
- Support the documentation and review process for Standard Operating
- Procedures (SOPs), Work Instructions (WIs), and other quality documents.
- Participate in internal audits and inspections to ensure compliance with regulatory and quality requirements.
- Assist in the investigation and documentation of non-conformities and the implementation of corrective and preventive actions (CAPAs).
- Assist with document control activities, ensuring that all regulatory and quality documents are properly maintained and accessible.
- Help manage the document review and approval process, ensuring timely updates and accuracy of records.
- Participate in training sessions on regulatory and quality requirements and best practices.
- Assist in the development of training materials and presentations for staff education.
- Support project management activities by tracking progress, updating project plans, and ensuring deadlines are met.
- Assist in the coordination of cross-functional team meetings and activities related to regulatory and quality projects.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related field.
- Currently pursuing or recently completed a postgraduate program in Regulatory Affairs.
- Strong interest in regulatory affairs and quality assurance within the medical device industry.
- Basic understanding of FDA, Health Canada, EU MDR, and other relevant medical device regulations is a plus.
- Excellent organizational and time management skills with a strong attention to detail.
- Good analytical and problem-solving abilities.
- Effective communication skills, both written and verbal.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to work independently as well as part of a team.
- Enthusiastic and eager to learn.
- Strong interpersonal skills with the ability to work collaboratively with cross-functional teams.
- Proactive and self-motivated with a strong sense of responsibility.
- Ability to handle multiple tasks and prioritize effectively.
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