Quality Assurance Regulatory Affairs Manager
Top Benefits
About the role
At Stoko, we know that life is better when we are able to do the activities we love. That’s why we’ve created the world’s first and only Supportive Apparel that’s proven to help people get active again and stay active for as long as possible. Based in Vancouver, British Columbia, we have assembled a multi-disciplinary team of dreamers, designers, and disruptors who are up for the challenge of creating a brand new consumer category and learning a thing or two along the way.
Sound like something you’d like to be a part of? Perfect, keep reading.
Start Date: August 2026 Compensation: $95,000 – $125,000 + Variable Compensation
About the Role: Stoko is a Medical Device company, and our Supportive Apparel products are all Class I Medical Devices. We are seeking a dedicated QA/RA Manager to take ownership of our Quality Management System and regulatory operations. In this critical role, you will take ownership of our existing quality systems, evolving and scaling them, lead our international regulatory strategy, and serve as the dedicated, objective voice for risk management and product compliance. You will collaborate deeply with our product and operations teams to embed quality and regulatory rigour throughout the product lifecycle.
Roles & Responsibilities Global Quality Management System (QMS) Ownership Own, evolve, and continuously improve our QMS, ensuring it meets the strict standards for Class I medical devices, across all geographies we operate in, while remaining agile and relevant for technical apparel production. Manage, execute, and adhere to strict timelines for critical systems, including Corrective and Preventive Actions (CAPA), complaint handling, management reviews, and quality audits. Collaborate with the product team to establish and enforce medical regulatory standards during all aspects of product realization, manufacturing, and the total product lifecycle.
International Regulatory Strategy & Compliance Own the entire regulatory lifecycle for Class I medical device products, including strategy, applications, device listing, and establishment registration. Lead international regulatory initiatives, spearheading new market entry to maintain compliance. Manage and set standards for international chemical compliance, including ISO 10993, Prop 65, and REACH. Set corporate standards for evidence and oversee the approval of medical claims.
Post-Market Surveillance & Investigations Own the post-market surveillance process, providing end-to-end oversight of a unified customer complaint handling lifecycle. Lead formal product investigations, which will include direct consultations with physicians and healthcare professionals, and overseeing formal documentation. Develop and maintain robust frameworks to proactively quantify, analyze, and execute against total product risk.
Qualifications & Experience Experience: 3+ years of proven experience in a quality systems and regulatory affairs role, ideally managing medical devices (specifically Class I). Regulatory Expertise: Deep knowledge of medical device regulations (FDA QSR, Health Canada) and an understanding of general consumer apparel safety standards. Experience managing a QMS compliant with ISO 13485 is highly preferred. Systems Building: A strong track record of establishing, scaling, and managing quality and regulatory frameworks in a fast-paced or high-growth environment. Communication & Clinical Engagement: Proven ability to communicate complex regulatory concepts clearly and a track record of engaging effectively and professionally with medical professionals and physicians. Risk Management: Demonstrated ability to independently quantify, analyze, and execute against risk frameworks without compromising product innovation timelines. Bonus Expertise: Experience with textile quality, garment construction, and apparel manufacturing processes is a strong asset, though not strictly required if regulatory fundamentals are exceptional. Education: A degree in Regulatory Affairs, Quality Management, Biomedical Engineering, Life Sciences, or a related field. Awesomeness.
Perks and Benefits: We are a team that loves to laugh together, learn from each other, and take care of one another. As a full-time employee at Stoko, you will be eligible to receive a benefits package, as well as a health spending account to cover healthcare costs such as dental, vision care, RMT and more. Additionally, Stoko offers flexible schedules, unlimited coffee, team bonding, and an environment that fosters creativity, growth, and real responsibility.
Still excited? Awesome. Send us an email at jobs@stoko.ca! Please include a resume and a cover letter explaining why you’re excited and why you’re a great fit for our team.
Not the right fit? Search for Quality Assurance Regulatory Affairs Manager jobs in Vancouver, British Columbia, Canada
About Stoko
Stoko was born because we were sick and tired of being held back by different injuries. We believe that people should be able to be as active as they want to be, regardless of their athletic ability, age, or previous injuries.
We exist to empower an active lifestyle and are on a mission to help people get active again and stay active for as long as possible.
Similar Jobs
Quality Assurance Regulatory Affairs Manager
Top Benefits
About the role
At Stoko, we know that life is better when we are able to do the activities we love. That’s why we’ve created the world’s first and only Supportive Apparel that’s proven to help people get active again and stay active for as long as possible. Based in Vancouver, British Columbia, we have assembled a multi-disciplinary team of dreamers, designers, and disruptors who are up for the challenge of creating a brand new consumer category and learning a thing or two along the way.
Sound like something you’d like to be a part of? Perfect, keep reading.
Start Date: August 2026 Compensation: $95,000 – $125,000 + Variable Compensation
About the Role: Stoko is a Medical Device company, and our Supportive Apparel products are all Class I Medical Devices. We are seeking a dedicated QA/RA Manager to take ownership of our Quality Management System and regulatory operations. In this critical role, you will take ownership of our existing quality systems, evolving and scaling them, lead our international regulatory strategy, and serve as the dedicated, objective voice for risk management and product compliance. You will collaborate deeply with our product and operations teams to embed quality and regulatory rigour throughout the product lifecycle.
Roles & Responsibilities Global Quality Management System (QMS) Ownership Own, evolve, and continuously improve our QMS, ensuring it meets the strict standards for Class I medical devices, across all geographies we operate in, while remaining agile and relevant for technical apparel production. Manage, execute, and adhere to strict timelines for critical systems, including Corrective and Preventive Actions (CAPA), complaint handling, management reviews, and quality audits. Collaborate with the product team to establish and enforce medical regulatory standards during all aspects of product realization, manufacturing, and the total product lifecycle.
International Regulatory Strategy & Compliance Own the entire regulatory lifecycle for Class I medical device products, including strategy, applications, device listing, and establishment registration. Lead international regulatory initiatives, spearheading new market entry to maintain compliance. Manage and set standards for international chemical compliance, including ISO 10993, Prop 65, and REACH. Set corporate standards for evidence and oversee the approval of medical claims.
Post-Market Surveillance & Investigations Own the post-market surveillance process, providing end-to-end oversight of a unified customer complaint handling lifecycle. Lead formal product investigations, which will include direct consultations with physicians and healthcare professionals, and overseeing formal documentation. Develop and maintain robust frameworks to proactively quantify, analyze, and execute against total product risk.
Qualifications & Experience Experience: 3+ years of proven experience in a quality systems and regulatory affairs role, ideally managing medical devices (specifically Class I). Regulatory Expertise: Deep knowledge of medical device regulations (FDA QSR, Health Canada) and an understanding of general consumer apparel safety standards. Experience managing a QMS compliant with ISO 13485 is highly preferred. Systems Building: A strong track record of establishing, scaling, and managing quality and regulatory frameworks in a fast-paced or high-growth environment. Communication & Clinical Engagement: Proven ability to communicate complex regulatory concepts clearly and a track record of engaging effectively and professionally with medical professionals and physicians. Risk Management: Demonstrated ability to independently quantify, analyze, and execute against risk frameworks without compromising product innovation timelines. Bonus Expertise: Experience with textile quality, garment construction, and apparel manufacturing processes is a strong asset, though not strictly required if regulatory fundamentals are exceptional. Education: A degree in Regulatory Affairs, Quality Management, Biomedical Engineering, Life Sciences, or a related field. Awesomeness.
Perks and Benefits: We are a team that loves to laugh together, learn from each other, and take care of one another. As a full-time employee at Stoko, you will be eligible to receive a benefits package, as well as a health spending account to cover healthcare costs such as dental, vision care, RMT and more. Additionally, Stoko offers flexible schedules, unlimited coffee, team bonding, and an environment that fosters creativity, growth, and real responsibility.
Still excited? Awesome. Send us an email at jobs@stoko.ca! Please include a resume and a cover letter explaining why you’re excited and why you’re a great fit for our team.
Not the right fit? Search for Quality Assurance Regulatory Affairs Manager jobs in Vancouver, British Columbia, Canada
About Stoko
Stoko was born because we were sick and tired of being held back by different injuries. We believe that people should be able to be as active as they want to be, regardless of their athletic ability, age, or previous injuries.
We exist to empower an active lifestyle and are on a mission to help people get active again and stay active for as long as possible.