Regulatory Affairs Project Manager (Hybrid)

at  Kardium Inc

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 – we have a fantastic technical team that has developed a product with strong, unique, and customer-valued differentiators versus other solutions on the market. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.
We have now completed our pivotal clinical study and our focus is on regulatory approvals and commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.
As a Regulatory Affairs (RA) Project Manager (PM), you will work with the RA Team to bring innovative and highly complex medical devices to the market and maintain their regulatory compliance. Reporting to the RA Manager, the role will involve working with technical leaders, product / project managers, and RA Team members to manage timelines for submissions of market authorizations, clinical investigations, and product renewals.
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Meaningful work you will be a part of

• Manage multiple projects concurrently through all phases of the project life cycle to completion, including planning, scheduling, budgeting of resources both internal and external, project controls, risk management, and reporting, and executing all activities required for each project.
• Work closely with Regulatory Affairs management to ensure that strategies are well informed and implemented.
• Gather regulatory project requirements from internal stakeholders.
• Assist Regulatory Affairs Specialists in the communication and tracking of deliverables from internal and external stakeholders to ensure that projects remain timely.
• Create project plans that include a schedule with activities, deliverables, dependencies, milestones, risks, and issues.
• Exercise effective critical thinking in balancing short-term tactical delivery of solutions with long-term business needs.
• Collaborate with the RA Team, Systems Engineering Team, Information Systems Team, Engineering Team, and other teams, to develop and maintain systems required to support regulatory documentation, submissions, and operations, including systems for tracking submissions, regulatory documentation maintenance (e.g., Design History File, etc.), and tracking of regulatory status of products for distribution control.
• Monitor and communicate relevant updates on the EU, US, Canadian, and international regulations, guidance, and standards, and facilitate impact assessments.
• Provide project support on general Regulatory Affairs activities.
• Participate in the continuous improvement of current processes in collaboration with other managers.
• Lead by example and be an ambassador for the company culture and values.
  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:

• Either a Bachelor of Science or Engineering degree
• A minimum of either:
• Three years of relevant Regulatory Affairs experience, or equivalent combination of post-graduate education and experience with at least one year in a leadership position; or
• Three years of project management experience in a regulated industry.
• Experience with high-risk medical devices, In-Vitro Diagnostics, or pharmaceuticals
• Excellent written and verbal communication
• Excellent technical documentation skills with proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) and project management tools such as SmartSheets
• Strong time management with a sense of urgency, agility, transparency, respect, and collaboration in a team setting
• Ability to take initiative and uphold project timelines by holding relevant parties accountable
• In-depth working knowledge of European, US, and Canadian medical device regulatory requirements is an asset

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.

• $77,000 - $96,000 (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?
1. Our Purpose
2. Our People
3. 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