Medical Device Regulatory jobs in Vancouver, BC

Your opportunity

By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation – which can cause stroke, heart failure, and other heart-related complications.

Kardium’s mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe® Pulsed Field System – a revolutionary solution designed by our world-class technical team. The Globe System offers strong, unique, and customer-valued advantages over other treatments on the market, and leading physicians are already using it and helping to share our story.

We have obtained FDA approval and officially begun the commercial launch of the Globe® Pulsed Field System. This is a pivotal and exciting time in our journey, as we bring this life-changing technology to patients!

At Kardium, we're looking for experienced QA Specialists to join our team. You'll be at the heart of the action, working directly alongside our Manufacturing and Engineering teams to ensure excellence at every step. You'll also play a key role in shaping and improving our Quality Management System (QMS). ! You'll work a consistent 5-day week on one of two schedules:

Sunday to Thursday

Or

Tuesday to Saturday

Morning shifts starting at 7:00 AM, evening shifts wrapping up around 7:30 PM, and occasional statutory holiday coverage are part of the mix, allowing for weekend flexibility. Premium pay applies for noncore hours worked on Saturday, Sunday, and weekdays after 6:00 PM.

Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.

Meaningful work you will be a part of

Your responsibilities will include:
Support Manufacturing & Engineering Teams

• Review production and engineering documentation, from Device Master Records and DHRs to verification/validation plans, test protocols, and change requests
• Execute QA release of incoming materials, in-process goods, and finished products
• Contribute to root cause investigations, process validations, and equipment qualifications
• Review software tool implementation and validation documentation

Strengthen Our Quality Management System

• Participate in internal audits and manage QMS project activities
• Maintain document control in line with Kardium policies and procedures

What you bring to the team

Our Kardium team is smart, creative, and passionate about developing cutting-edge medical devices to help improve people’s lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable.

You will be successful in this role because you possess these attributes:

Education & Experience

• Bachelor's degree in a technical discipline (e.g., engineering, biotech, pharmaceutical sciences)
• 3+ years of QA experience in biotech or medical device manufacturing
• Strong working knowledge of ISO 13485, FDA QSR, and EU MDD requirements
• Familiarity with document control systems (electronic systems a plus)

Skills & Attributes

• Sharp analytical and critical thinking abilities
• Clear, effective communication—both written and verbal
• Highly organized with strong attention to detail
• Self-directed, yet collaborative across all levels of the organization
• Flexible, adaptable, and solution-oriented

Compensation

Kardium has listed the total cash compensation range (base salary + 5% RRSP contribution) that we expect to pay applicants for this role, as of the time of this posting. Pay offered will be determined based on numerous relevant business and candidate factors including, for example, education, qualifications, certifications, experience, skills, and business or organizational needs. For candidates with more or less experience than listed above, the pay range will be adjusted.

As a permanent employee, you will also participate in Kardium’s stock option plan.

$69,500 - $90,000 (CAD Annually)

 Your Benefits & Well-being

Total cash – the total cash we’ve listed for this position includes a base salary, plus a contribution to a Registered Retirement Savings plans (RRSP) to help support your financial goals.

Comprehensive medical & dental coverage – for all permanent employees – effective as of Day 1, with no waiting period.

Work-day flexibility – additionally, we provide 3 personal days per year.

Support – for you (and your dependents) overall well-being.

Career progression and learning support.

Professional membership support.

Family building – we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment.

Life at Kardium

What makes us a great place to work?

• Our Purpose
• Our People
• Our Culture

At Kardium, we embrace diversity of background, experience, and perspective and we’re committed to inclusion and equity at every level. We encourage applications from all qualified candidates who represent the full diversity of all communities.

We collaborate with Employee Resource Groups (ERGs), as volunteer-led groups who share a common dimension of diversity and come together to provide support, education, and other opportunities across Kardium. Examples of our ERGs include Women ERG, Pride ERG, Race Ethnicity & Cultural Heritage (REACH) ERG, Truth & Reconciliation ERG, Persian Community ERG, Chinese ERG, Barangay Kardium (Filipino) ERG, Brazilian ERG and Irish ERG.

As part of your application, we encourage you to note if you require an accommodation for the recruitment process (including alternate formats of materials, accessible meeting rooms or other accommodations). There will be an optional section in the application form where you can provide this information to the recruitment team.

And our employees think we are great too – check out Glassdoor to learn more!