Regulatory Affairs Project Manager

7 days ago

Burnaby, Canada Kardium Inc. Full time

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
**Your responsibilities will include**:

- 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
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.
Compre

  • Regulatory Affairs Project Manager Expert

    4 days ago

    Burnaby, British Columbia, Canada Kardium Full time

    Job OverviewKardium, a leading medical device company, is seeking a highly skilled Regulatory Affairs Project Manager to join our team. As a key member of the regulatory affairs department, you will be responsible for managing multiple projects simultaneously, ensuring timely completion, and maintaining regulatory compliance.

  • Regulatory Affairs Project Manager

    4 days ago

    Burnaby, British Columbia, Canada Kardium Full time

    Regulatory Affairs Project Manager (Hybrid)Kardium Inc., 155-8518 Glenlyon Parkway, Burnaby, British Columbia, Canada Req #201January 21, 2025Your opportunityBy 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...

  • Regulatory Affairs Manager

    2 weeks ago

    Burnaby, Canada Artron Laboratories Inc. Full time

    Artron Laboratories Inc is a technology-based manufacturer specialized in the development and large-scale production of lateral flow rapid test kits. Artron established itself in the progression of in vitro diagnostic lateral flow tests that have revolutionized the market for disease diagnosis and analyte detection. At Artron, we are committed to going above...

  • Project Manager, Regulatory Affairs

    5 days 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...

  • Project Manager Regulatory Affairs

    4 days ago

    Burnaby, British Columbia, Canada Kardium Full time

    What You'll BringA Bachelor's degree in Science or Engineering, or equivalent experience.A minimum of three years of relevant RA experience, or equivalent combination of post-graduate education and experience, with at least one year in a leadership position.Excellent technical documentation skills and proficiency in Microsoft Office Suite and project...

  • Regulatory Affairs Coordinator

    7 days ago

    Burnaby, Canada Daiya Foods Inc. Full time

    Welcome to the unexpected delight of plant-based exploration! We're the creators of a revolutionary cheese alternative that tastes, shreds, melts and stretches like traditional cheese. Today, as plant-based food grows in popularity, that spirit of innovation continues to inspire our team. We believe in pioneering plant-based breakthroughs that delight...

  • Regulatory Affairs Specialist

    2 weeks ago

    Burnaby, Canada Kardium Inc. Full time

    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...

  • Risk and Regulatory Affairs Business Planning Analyst

    4 weeks ago

    Burnaby, Canada BC Housing Full time

    **Position Summary**: **RISK AND REGULATORY AFFAIRS BUSINESS PLANNING ANALYST** **JOB ID: 6153** **REGULAR/FULL-TIME** **LOCATION: BURNABY, B.C** - ** Join one of BC’s Top Employers!**: - ** Be part of an exceptional company culture with great employee benefits and a healthy work/life balance!** **BC Housing thanks all applicants for their interest;...

  • Regulatory Affairs Team Lead

    4 days ago

    Burnaby, British Columbia, Canada Kardium Full time

    ResponsibilitiesManage multiple projects through all phases, from planning to completion, ensuring timely delivery and regulatory compliance.Collaborate with the RA team, technical leaders, and product/project managers to develop strategies and implement them effectively.Gather project requirements from internal stakeholders and communicate with external...

  • Senior Regulatory Affairs Specialist

    6 days ago

    Burnaby, British Columbia, Canada Delta Q Full time

    About UsAt Delta-Q Technologies, we are passionate about creating a sustainable business and contributing to a greener future for the world. We strive to innovate and improve our products and processes when it's a competitive advantage.Job SummaryThe Senior Regulatory & Compliance Engineer is responsible for managing product compliance with international...

  • Vice President, Quality and Regulatory Affairs

    2 weeks ago

    Burnaby, British Columbia, Canada Corporate Recruiters Ltd. Full time

    We are seeking an experienced Vice President of Engineering & Operations to lead and scale our engineering and production teams in RF communication systems. Reporting directly to the CEO, this role is responsible for aligning technical expertise with operational efficiency to ensure high-quality product delivery on time and within budget. We are a high-tech...

  • Regulatory Affairs Co-op

    7 days ago

    Burnaby, Canada Kardium Inc. Full time

    Regulatory Affairs Co-op (Hybrid) **Term**: May 2025 **Duration**: 4 months, with the possibility of extension **Openings**: 1 position **Salary Range**: $3,650 - $4,525 CAD per month **Application Deadline**: Friday, January 17, 2025 Your opportunity By joining the Kardium team, you can help make a difference in the lives of millions around the world. We...

  • Permitting and Regulatory Manager

    2 weeks ago

    Burnaby, Canada Parkland Refining BC Ltd Full time

    At Parkland, our purpose is to Power Journeys & Energize Communities. We are a prominent independent supplier and marketer of fuel and petroleum products and a leading convenience store operator. As One Parkland team, we proudly serve diverse retail, commercial and wholesale customers across Canada, the United States, the Caribbean region, and South America....

  • Healthcare and Regulatory Compliance Administrator

    2 weeks ago

    Burnaby, Canada Sprott Shaw College Full time

    _**Are you motivated by using your talents to support others? Come work for one of BC’s top private colleges!**_ - Established in 1903, Sprott Shaw College is a private post-secondary institution with 16 government-designated campuses across British Columbia. We take great pride in educating and preparing our students for rewarding and relevant careers in...

  • Manager, Community

    5 days ago

    Burnaby, Canada BC Housing Full time

    **Position Summary**: **MANAGER, COMMUNITY & TENANT AFFAIRS** **Job ID: 4591** **REGULAR/FULL-TIME** **Location: BURNABY, BC** - **Join one of BC’s Top Employers!**: - **Be part of an exceptional company culture with great employee benefits and a healthy work/life balance!** **BC Housing thanks all applicants for their interest; only those selected...

  • Senior Regulatory

    4 weeks ago

    Burnaby, British Columbia, Canada Delta Q Full time

    About Delta-Q Technologies:Delta-Q Technologies (www.delta-q.com) develops and supplies battery chargers to original equipment manufacturers (OEMs) of electric vehicles and industrial equipment. Delta-Q's unique blend of engineering capability in high-efficiency power electronics and embedded software design delivers innovative battery charging solutions to...

  • Manager of Public Affairs

    4 weeks ago

    Burnaby, British Columbia, Canada The Salvation Army in Canada Full time

    Mission Statement The Salvation Army exists to share the love of Jesus Christ, meet human needs and be a transforming influence in the communities of our world. Vision Statement We are an innovative partner, mobilized to share hope wherever there is hardship, building communities that are just and know the love of Jesus. Core Values The Salvation Army...

  • Manager of Public Affairs

    4 weeks ago

    Burnaby, Canada The Salvation Army in Canada Full time

    Mission Statement The Salvation Army exists to share the love of Jesus Christ, meet human needs and be a transforming influence in the communities of our world. Vision Statement We are an innovative partner, mobilized to share hope wherever there is hardship, building communities that are just and know the love of Jesus. Core Values The Salvation Army...

  • Regulatory Compliance Engineer III

    4 weeks ago

    Burnaby, Canada Verathon Full time

    Company Overview Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement...

  • 15h Left Regulatory Compliance Engineer III

    3 weeks ago

    Burnaby, British Columbia, Canada Verathon Full time

    Company OverviewVerathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and...