Project Manager, Regulatory Affairs

6 months ago

Burnaby, Canada Kardium Full time

**Your opportunity**

By joining the Kardium team, you can help make a difference in the lives of millions around the world. Kardium is developing a ground breaking medical device for the mínimally-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications.

Kardium has a fantastic technical team that has developed a product with strong, unique and customer-valued differentiators versus other solutions on the market: The Globe® Pulsed Field System. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.

As a Project Manager (PM), Regulatory Affairs (RA) 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 managers, 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.

**What you'll be doing**

Your responsibilities will include:

- Manage multiple RA projects concurrently through all phases of the project lifecycle to completion, including planning, scheduling, budgeting of resources both internal and external, conducting project risk management, monitoring, and control, as well as execution of all activities required for each project and status reporting to Management as needed.
- Create project plans that include a schedule with activities, deliverables, dependencies, milestones, risks, and issues.
- Gather project requirements from internal stakeholders including Clinical Engineering and Operations, Product Development, RA, and other teams as applicable.
- Assist RA Team members in the communication and tracking of deliverables from internal and external stakeholders to ensure that projects remain timely.
- Collaborate with the RA Team, Systems Engineering Team, Information Systems Team, and other teams, to develop and implement systems required to support regulatory documentation, submissions and operations, including systems for tracking submissions, and changes thereof, sent to regulators and partners, regulatory documentation maintenance (e.g., Device Master Record, Design History File, etc.), and tracking of regulatory status of products and changes thereof for distribution control purposes.
- Exercise effective critical thinking in balancing short-term tactical delivery of solutions with long-term business needs.
- Provide project support on general RA activities.
- Work with the RA Manager on leadership development by contributing to Talent Management initiatives and engaging in appropriate performance and development planning 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 creating cutting-edge medical devices to help improve people's lives. We work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable.

You are suited to our approach and 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 Microsoft Project and SmartSheets
- Strong time management with a sense of urgency, agility, transparency, respect, and collaboration in a team setting
- In-depth working knowledge of European, US, and Canadian medical device regulatory requirements (e.g., EU MDR, ISO 13485, U.S. QSR, etc.) and privacy regulations (e.g., GDPR, PIPEDA, etc.) is an asset

**Compensation**
- $90,000 - 116,200 (CAD Annually)

**Why work at Kardium**

A meaningful career working with a truly innovative technology and an ambitious team, combined with:

- Knowing every day that you are making a difference in people's lives by helping treat a condition that debilitates millions worldwide
- A great working environment with opportunities to develop your skills and knowledge
- Opportunity to extend your knowledge by interacting with other team members in a multi-disciplinary environment that includes electrical and mechanical engin

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