Manager, Quality Assurance and Regulatory Affairs

**About Cloud DX**

Cloud DX is an industry leader in digital health care, virtual care, remote patient monitoring hardware and software. The company’s award-winning solutions enable chronically ill patients to stay at home and out of the hospital, drastically improving health outcomes while, at the same time, significantly reducing costs to treat the most expensive patients in the healthcare system. Cloud DX is relentlessly committed to serving patients, driving Innovation, delivering results, and making a difference in communities across North America and globally. The Company was founded in 2014 and has grown into a leader in the Virtual Care Market in North America. The current COVID crisis has accelerated the adoption of virtual care in our markets and Cloud DX is investing in expanding our US Sales and Marketing efforts.

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The Role*

Cloud DX is growing, and we are looking for a Quality and Regulatory Affairs Manager to join our growing team. In this role, you will be responsible for the implementation and maintenance of the Quality Management System (QMS) and regulatory strategies to meet requirements in regions where products are distributed. Responsibilities include the planning, preparation, maintenance and improvement of the QMS and applicable regulatory affairs activities. This role is responsible for maintaining relationships with internal teams and ensuring their compliance with policies and procedures.

**What You'll Do**
- Review and implement QMS procedures and processes. Assist with the maintenance and continuous improvement of the QMS, including writing and revising SOPs, work instructions, templates and forms to be compliant with ISO 13485, MDSAP, FDA QSR and CMDR.
- Ensuring compliance with ISO13485:2016, FDA's Quality Systems Regulations (QSR), Canadian Medical Device Regulations, GMPs, and other regulatory requirements where the product is distributed.
- Assist with regulatory strategy development and implementation of the strategic plans, including investigational studies and regulatory approval plans for commercialization. Also, maintain documentation and regulatory certifications for existing products
- Provide managerial oversight and guidance to the team and quality and regulatory communications with internal and external stakeholders.
- Assist with reviewing Medical Device Files (Design History Files, Device MasterRecords), regulatory product submissions, and approval records.
- Approve promotional materials for regulatory compliance.
- Ensure that all employees are familiar with, trained on, and follow all QMS procedures related to their jobs which can affect the quality of products.
- Evaluate changes to controlled documents for impact on submissions and filing requirements, including providing a technical review of and approval for proposed changes and supporting documentation.
- Review and or approve complaints, including reportability assessment, CAPAs, non-conformance reports and/or recall activities.
- Participate in 3rd party internal and external audits and inspection activities (ISO, FDA, Health Canada). Track and respond to audit items. Travel for audits may be required.
- Identify quality issues, including supplier issues, and report to management in a timely manner.
- Keep abreast of US and Canadian medical device regulations
- Assist with other duties as assigned

**Who You Are**
- Minimum 5 years of Regulatory Affairs and Quality Systems management experience within the medical device industry
- Excellent written and verbal communication skills
- Experience in supervisory and managerial positions
- Strong time management skills
- You understand Root Cause analysis and are familiar with the CAPA process
- Organized, attentive to detail and able to prioritize and handle multiple projects with competing deadlines
- The ability to travel to the Kitchener office as required

**Bonus**
- Hardware, manufacturing, and/or software as a medical device (SaMD) experience
- Certificates for ISO 13485:2016 internal auditor training and/or MDSAP overview
- Certification in a regulatory or quality discipline, such as RAC, ASQ Certification