Regulatory Manager

6 months ago

Mississauga, Canada Myant Full time

**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.

hQOtNlHPnH

  • Manager, Regulatory

    7 months ago

    Mississauga, Canada IMS Full time

    Working with us you’ll have a unique opportunity to experience the evolving technological frontier! **Job Purpose** **Duties and Responsibilities** Specifically, but not limited to: - Develop, implement and maintain a comprehensive quality management system and processes in accordance with applicable regulatory requirements (e.g., FDA QSR, ISO 13485,...

  • Regulatory Affairs Manager

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...

  • Regulatory Affairs Manager

    1 day ago

    Mississauga, Canada Merck KGaA Darmstadt Germany Full time

    A career with EMD Serono is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of...

  • Regulatory Compliance Manager

    6 months ago

    Mississauga, Canada Delmar International Inc. Full time

    **Mandate**: Reporting to the Vice President of North American Customs Services, the **Regulatory Compliance Manager **will be responsible for providing the full range of Canadian customs regulatory and advisory services to support our clients as well as the internal staff. **Other Responsibilities**: - Manage customs technical inquiries related to client...

  • Project Manager, Regulatory Affairs

    4 months ago

    Mississauga, Canada AstraZeneca Full time

    Prepares/executes global/regional regulatory tactical submission plans on allocated projects/products that implement the agreed regulatory strategy to develop and maintain products. Generates/project manages delivery, to time/quality of submissions. Demonstrates in depth knowledge of Regulatory compliances and submissions. Develops and builds good...

  • Manager, Regulatory Asset Oversight

    2 weeks ago

    Mississauga, Canada GSK Full time

    **Site Name**: Mississauga Milverton Drive **Posted Date**: Dec 17 2024 **Job Purpose** **Join Our Team as a Regulatory Asset Oversight Manager!** **Details (Your Responsibilities)**: In close collaboration with the GRL and RMT, develop and maintain a holistic view of the global regulatory integrated plan at the asset level for operationalizing the Global...

  • Regulatory Compliance

    1 month ago

    Mississauga, Canada Advanced Technology Search Group Full time

    **Job Type**: Full Time **Location**: Mississauga, ON Date Posted: 2024-11-19 Job ID: N4867152 **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...

  • Manager- Regulatory Artwork

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...

  • Regulatory Affairs Manager

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...

  • Manager Gmp Regulatory Compliance

    7 months ago

    Mississauga, Canada Thermo Fisher Scientific Full time

    As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals...

  • Regulatory Chemical Compliance Manager

    1 month ago

    Mississauga, Canada Brenntag Specialities Full time

    p>Our team in Mississauga currently has an opening for a Regulatory Affairs Manager.YOUR ROLE & RESPONSIBILITIESJob Summary:To provide support to the organization in maintaining compliance and addressing needs related to new and existing business as they pertain to regulatory matters.Job Description:Manage risk considering legal compliance requirements,...

  • Regulatory Affairs Manager, Vaccines

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **About us**: Are you passionate about **science** and experienced within **drug development** and **regulatory affairs**_? _Would you like to combine your **project management skills** with your experience of working cross functionally and globally? At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’...

  • Regulatory Information Management Systems, Manager

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...

  • Aircraft Regulatory

    2 months ago

    Mississauga, Canada Brenntag Specialities Full time

    p>Our team in Mississauga currently has an opening for a Regulatory Affairs Manager.YOUR ROLE & RESPONSIBILITIESJob Summary:To provide support to the organization in maintaining compliance and addressing needs related to new and existing business as they pertain to regulatory matters.Job Description:Manage risk considering legal compliance requirements,...

  • Cmc Regulatory Affairs Manager- Submission

    4 days ago

    Mississauga, Canada AstraZeneca Full time

    Join AstraZeneca, a place built on innovation and creativity. Where different views and perspectives are encouraged and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve. We are looking for a **Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Associate** to join us on a...

  • International Cmc Regulatory Affairs Manager

    8 months ago

    Mississauga, Canada AstraZeneca Full time

    **Job Description**: **About AstraZeneca** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then...

  • Cmc Regulatory Affairs Manager, Submission

    3 months ago

    Mississauga, Canada AstraZeneca Full time

    **At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.**: **Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...

  • Regulatory Affairs Manager

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...

  • Regulatory Affairs Cmc Manager

    2 months ago

    Mississauga, Canada GSK Full time

    **Site Name**: Mississauga Milverton Drive **Posted Date**: Oct 31 2024 **Key Accountabilities/Responsibilities**: - Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization area - Accountable for a portfolio of products, including the preparation, filing and approval of...

  • Regulatory Affairs Manager, Vaccines

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    Are you passionate about science and experienced within drug development and regulatory affairs? Would you like to combine your project management skills with your experience of working cross functionally and globally? At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’ lives. That difference starts...