Work In Tech

About Orpyx

Orpyx is a leading digital therapeutics company that is committed to extending healthspan for people living with diabetes through personalized remote care. Our flagship product, the Orpyx SI® Sensory Insoles, is transforming diabetes care by helping prevent diabetic foot ulcers, a major complication of diabetes that can lead to amputation. Our dedicated remote patient monitoring team, comprised of credentialed providers and nurses, utilizes advanced data science methodologies to provide personalized support and triaged clinical escalation. With our whole-person approach, Orpyx empowers people to take control of their health, prevent debilitating complications and extend their healthspan. We are an ISO 13485 company committed to providing quality medical solutions that consistently meet customer needs and regulatory requirements.

Who we are

The people at Orpyx are flexible thinkers and creative innovators. We come from a variety of backgrounds and carry a wealth of expertise in multiple industries, including medical, technology, software, marketing, and finance. What we all have in common is an intense passion for the work we do. We have an extraordinary collection of talent that makes working here fun, unique and inspiring. Our hiring goal moving forward is to continue to build and grow a strong, effective team, while maintaining our friendly and innovative company culture.

What we offer

We offer an opportunity to work with cutting-edge medical technology that extends the healthspan of people living with diabetes. We offer a competitive salary and a comprehensive benefits package that includes medical, dental, and health or wellness spending account. Our flexible health benefits, RRSP matching program, and employee stock option plans allow for customized benefits that meet your individual needs. In addition, our employees receive 4 weeks’ vacation to start and paid flex and health days, giving them ample opportunity to rest and recharge. We have team events every second Friday, and annual in-person events, which contribute to a positive work culture and foster team connections.

What you'll do

Reporting to the Chief Operations Officer and working as part of a cross-functional team, the Quality Assurance & Regulatory Affairs Manager (QA & RA Manager) is responsible for ensuring that our products meet the highest quality standards and comply with the relevant medical device regulations. The successful candidate is responsible for ensuring the organization maintains an effective quality management system that meets ISO 13485 and applicable regulatory requirements and will be appointed the quality management representative with the associated responsibilities and authorities to ensure effective operation of the Quality Management System (QMS).

Quality Assurance Management (QA)

• Develop, implement, and maintain the ISO 13485-certified QMS (Quality Management System) to ensure ongoing compliance
• Manage and maintain the CAPA (Corrective and Preventive Action) program, non-conformances, and deviations to ensure continuous improvement
• Lead risk management activities in compliance with ISO 14971
• Ensure effective document control and record-keeping in line with QMS requirements
• Develop, implement, and maintain QMS policies and processes to ensure product quality and compliance with industry standards
• Establish and enforce quality control processes throughout the product lifecycle, from design and development to manufacturing and distribution
• Monitor and report on the effectiveness of the Orpyx QMS
• Work with executive team on QMS related planning and setting quality policies and objectives
• Work with cross-functional teams to address quality issues and provide strategic input
• Drive the development of an annual compliance schedule in coordination with internal groups
• Stay abreast of relevant regulations, standards, and guidelines applicable to the medical device and healthcare industry
• Oversee and coordinate internal and external audits, including regulatory inspections and supplier audits
• Foster a culture of continuous improvement and identify opportunities for training & development with respect to Quality Management and the QMS
• Develop and provide training to employees on quality processes, standards, and compliance

Regulatory Affairs Management (RA)

• Act as the primary point of contact for regulatory agencies and notified bodies on all issues arising out of the development, commercialization, and manufacturing of Orpyx products
• Work with regulatory bodies to ensure timely approvals and requirement compliance
• Develop and execute regulatory strategies to support product approvals and market entry
• Work with cross-functional teams to address regulatory issues and provide strategic input
• Provide regulatory guidance to internal teams ensuring submissions are accurate and complete
• Prepare and submit regulatory documents to health authorities and regulatory agencies
• Lead regulatory activities related to advisory notices, recalls and removals
• Prepare and submit regulatory filings (e.g., 510(k), CE Marking, MDR submissions, Health Canada, etc.)
• Stay updated on global regulatory changes (FDA, EU MDR, ISO 13485, MDSAP, etc.) and ensure company compliance
• Ensure effective document control and record-keeping in line with regulatory requirements
• Maintain technical files, design dossiers, and regulatory documentation
• Support post-market activities, including vigilance reporting and post-market surveillance
• Provide training to employees on regulatory requirements

General

• Prepare reports for management and regulatory agencies
• Build, lead, and develop a high-performing Quality Assurance and/or Regulatory team through recruitment, coaching, performance management, and career development to meet company growth needs
• Maintain a clean, and safe working environment
• Perform duties in a manner that is consistent with and committed to upholding the requirements of the quality management system

Additionally, due to the ever-changing and sometimes chaotic environment of an early-stage high-tech company, the QA & RA manager may assume additional responsibilities, as required

What you’ll bring

• Post-Secondary degree in Business, Engineering, or a related field
• Certified ISO 13485 Internal Auditor
• Completed training on current ISO 13485:2016 standard
• 5+ years of experience working in a medical device/equipment manufacturing industry
• 1+ years of supervisory experience, additional experience is considered an asset
• Experience with eQMS software considered an asset
• Demonstrated knowledge and experience managing Quality Management systems
• Demonstrated knowledge of MDSAP, ISO 13485,, ISO14971, Health Canada and FDA Title 21 regulations
• Excellent attention to detail, critical thinking, and analytical abilities
• Demonstrated decision-making and problem-solving skills
• Demonstrated ability to own and influence project and key results in a fast-paced environment
• Excellent communication and interpersonal skills, with a demonstrated ability to influence, interact and work effectively with key internal and external stakeholders
• Ability to identify potential problems and take appropriate action
• Very strong time management and organizational skills with the ability to prioritize and manage own workload whilst multi-tasking in order to meet deadlines
• Must thrive in a start-up, fast-paced, ever-changing work environment and be comfortable navigating the “grey”

The details

Application instructions and deadline: Please submit a cover letter and resume that outlines why your skills, experience and personality would make you an excellent candidate for this role at Orpyx by 1pm April 11, 2025.

Employment status: Permanent full time.

Schedule: 40 hours per week from Monday to Friday. Peaks and valleys may be required periodically, depending on operational needs. This role is not overtime eligible.

Work location: Calgary, Alberta. Please note that this position is required to work onsite at our Head Office located at Suite 205, 1240 – 20th Avenue S.E.

For more information, visit: https://www.orpyx.com