Regulatory Affairs Project Manager (Hybrid)

Kardium Inc.; Burnaby; Hybrid; CAD 77,000 - 96,000; Full time

Job summary

Join a forward-thinking company dedicated to transforming healthcare with innovative medical technology. As a Regulatory Affairs Project Manager, you will play a crucial role in managing projects that ensure the successful launch of a groundbreaking medical device designed to treat atrial fibrillation. This hybrid position offers the opportunity to work collaboratively with a passionate team, focusing on regulatory approvals and strategic planning. With a commitment to diversity and inclusion, the company fosters a supportive environment where your contributions will directly impact patient care and advance medical technology. If you are driven, innovative, and ready to make a difference, this is the perfect opportunity for you.

Benefits

Stock Options

Comprehensive Medical Coverage

Dental Coverage

Work Flexibility

Personal Days

Wellness Support

Career Development

Professional Memberships

Family Support

Qualifications

• 3+ years of experience in Regulatory Affairs or project management in a regulated industry.
• Strong understanding of medical device regulations in North America and Europe.

Responsibilities

• Manage projects across all phases including planning, scheduling, and budgeting.
• Collaborate with Regulatory Affairs to develop strategies and monitor regulations.

Skills

Regulatory Affairs

Project Management

Technical Documentation

Time Management

Critical Thinking

Education

Bachelor of Science

Bachelor of Engineering

Tools

Microsoft Office

SmartSheets

Job description

Regulatory Affairs Project Manager (Hybrid)

Kardium Inc., 155-8518 Glenlyon Parkway, Burnaby, British Columbia, Canada Req #201

January 21, 2025

Your opportunity

Join Kardium to make a difference in millions of lives. We have developed a groundbreaking medical device for diagnosing and treating atrial fibrillation, a common heart rhythm disorder that can lead to stroke and heart failure.

Our mission is to deliver the best treatment for atrial fibrillation through The Globe Pulsed Field System, supported by a talented technical team. We have established strong relationships with key opinion leaders who are already using our system and sharing our story.

Having completed our pivotal clinical study, we are now focusing on regulatory approvals and launching our product. This milestone marks a significant step in bringing this innovative technology to patients.

This role is a hybrid work arrangement based in Burnaby, BC.

Meaningful work you will be a part of

Your responsibilities include:

1. Managing multiple projects across all phases, including planning, scheduling, budgeting, risk management, and reporting.
2. Collaborating with Regulatory Affairs management to develop and implement strategies.
3. Gathering regulatory requirements from internal stakeholders.
4. Supporting Regulatory Affairs Specialists in tracking deliverables to ensure timely project completion.
5. Creating detailed project plans with schedules, milestones, risks, and issues.
6. Applying critical thinking to balance short-term solutions with long-term goals.
7. Developing systems to support regulatory documentation, submissions, and operations.
8. Monitoring updates on international regulations and assessing their impact.
9. Supporting general Regulatory Affairs activities.
10. Participating in continuous process improvements.
11. Leading by example and promoting company culture and values.

What you bring to the team

Our team is innovative, collaborative, and passionate about advancing medical technology. Success attributes include:

• Bachelor of Science or Engineering degree.
• At least three years of relevant Regulatory Affairs experience or project management experience in a regulated industry.
• Experience with high-risk medical devices, IVDs, or pharmaceuticals.
• Strong technical documentation skills and proficiency in Microsoft Office and project management tools like SmartSheets.
• Excellent time management, initiative, and accountability skills.
• Knowledge of European, US, and Canadian medical device regulations is an asset.

Compensation

Listed range: $77,000 - $96,000 CAD annually, including base salary and 5% RRSP contribution. Compensation will be adjusted based on experience and qualifications. Benefits include stock options, comprehensive medical and dental coverage from day one, work flexibility, personal days, wellness support, career development, professional memberships, family support, and more.

Life at Kardium

We value diversity, inclusion, and equity, fostering a collaborative environment through Employee Resource Groups (ERGs) such as Women ERG, Pride ERG, REACH, and others. We encourage applicants to specify any accommodations needed during the recruitment process. Learn more about us on Glassdoor!