Regulatory Manager

**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 têxtile is that primary interface, used in clothing, coverings, carpeting and more, we wear and are surrounded by têxtiles 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 têxtiles. Skiin is in market launch along with the Myant Health Platform and both have received Health Canada medical device licenses and will soon be 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 têxtile is the next medium to bridge that gap.

We are a multi-disciplinary technology team solving big challenges at the intersection of fashion, electronics, software, and data science.

**The Role**:
**Responsibilities**:

- Assist in the development and implementation of regulatory strategies for new medical device products or modifications to existing devices.
- Stay up to date with changes in regulations and standards that may impact the company's products.
- Prepare and submit regulatory reports and updates to regulatory authorities as required.
- Monitor changes in regulations and standards and assess their impact on product compliance.
- Collaborate with cross-functional teams to ensure premarket and commercial products meet quality and safety standards.
- Manage and complete assigned projects within the Regulatory and Quality and teams.
- Experience working with electronics QMS systems to maintain a comprehensive regulatory documentation system to ensure accessibility and traceability of regulatory information.
- Participate as an Internal Auditor.

**Qualifications**:

- Educational background: Degree in Engineering (Biomedical preferred), Software, or Applied Sciences or equivalent experience and knowledge.
- Experience/Certification in Regulatory Affairs covering Health Canada, the US (FDA), UK and the EU.
- Experience in Regulatory and Quality in a MDSAP/ISO 13485 certified QMS.
- Experience with both hardware and software medical products.
- Internal or external auditing experience in MDSAP and/or ISO 13485
- Strong understanding of Quality Engineering Principles, Quality Improvement processes.
- Familiar with Digital Health technology (IoT, patient worn medical devices)
- Strong collaboration, organizational and project management skills.
- Certification in Quality Management, Medical Device Auditor, Quality Engineer.

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