Regulatory Affairs Senior Specialist

at  Myant Corp

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:

• 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.

Myant is a diversified, equal opportunity employer. People with a disability or a special accommodation request may send an email to hr@myant.ca.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 5-7 years of experience in regulatory affairs within the medical device industry.
• In-depth knowledge of FDA, Health Canada, EU MDR, and other relevant medical device regulations. Proven experience with regulatory submissions and successful product approvals.
• Strong understanding of ISO 13485 and ISO 14971 standards.
• Excellent organizational, communication, and project management skills.
• Ability to work effectively in a fast-paced and dynamic environment.
• Proficient in using regulatory and quality management software and tools

The RA Specialist is responsible for assisting in managing the regulatory processes to ensure compliance with international medical device regulations. This role involves preparing and submitting regulatory documentation, liaising with regulatory authorities, and ensuring our products meet all relevant regulatory requirements.

Key Responsibilities:

• Develop and implement regulatory strategies for new and existing products to ensure compliance with global regulations.
• Work closely with cross-functional teams including R&D, Quality Assurance, and Marketing to integrate regulatory requirements into product development and lifecycle management.

Regulatory Submissions:

• Prepare and submit regulatory documents, including premarket notifications (510(k)s), premarket approval applications (PMAs), technical files, and design dossiers, to regulatory authorities such as the FDA, Health Canada, and EU Notified Bodies.
• Ensure timely submission and approval of regulatory filings to support product launches and modifications.

Regulatory Compliance:

• Monitor and interpret regulatory requirements, guidance documents, and industry standards to ensure compliance.
• Communicate regulatory requirements to internal stakeholders and provide regulatory support and guidance throughout the product development process.
• Maintain up-to-date knowledge of regulatory changes and industry trends, and assess their impact on company practices and products.

Quality Management System (QMS):

• Collaborate with the Quality Assurance team to ensure the QMS complies with ISO 13485 and other relevant standards.
• Participate in internal and external audits to ensure compliance with regulatory requirements.
• Support the implementation and maintenance of risk management processes in accordance with ISO 14971.

Regulatory Documentation and Labeling:

• Review and approve labeling, advertising, and promotional materials for regulatory compliance.
• Ensure all regulatory documentation is accurate, complete, and up-to- date.
• Maintain regulatory files and databases.

Regulatory Agency Interaction:

• Serve as the primary contact with regulatory authorities for product submissions, audits, inspections, and inquiries.
• Prepare for and manage regulatory agency meetings and inspections.
• Respond to regulatory agency questions and requests in a timely and accurate manner.

Training and Development:

• Develop and deliver training programs on regulatory requirements and best practices for staff.
• Mentor and develop junior regulatory staff, fostering a culture of continuous learning and improvement.

Project Management:

• Manage multiple regulatory projects simultaneously, ensuring they are completed on time and within scope.
• Develop and maintain project plans, timelines, and budgets for regulatory activities.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 5-7 years of experience in regulatory affairs within the medical device industry.
• In-depth knowledge of FDA, Health Canada, EU MDR, and other relevant medical device regulations. Proven experience with regulatory submissions and successful product approvals.
• Strong understanding of ISO 13485 and ISO 14971 standards.
• Excellent organizational, communication, and project management skills.
• Ability to work effectively in a fast-paced and dynamic environment.
• Proficient in using regulatory and quality management software and tools.

Key Competencies:

• Strong analytical and problem-solving skills.
• Detail-oriented with a commitment to accuracy and compliance.
• Ability to manage multiple projects and priorities effectively.
• Strong interpersonal skills with the ability to work collaboratively with cross- functional teams.
• Proactive and self-motivated with a strong sense of responsibility.
• Effective communicator with the ability to present complex information clearly and
• concisely.

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