Regulatory Affairs Specialist

3 weeks 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. We have developed a ground-breaking medical device for the mínimally invasive diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation. Atrial fibrillation can cause stroke, 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 Regulatory Affairs (RA) Specialist, you will work with the RA Team to bring innovative and highly complex medical devices to the market and maintain their regulatory compliance. The role will involve coordinating submissions for market authorizations, clinical investigations, and product renewals, as well as providing regulatory input on the development of products and processes internally. This position will report to the RA Manager.
**What you'll be doing**
Your responsibilities will be to:

- Provide regulatory affairs input into product development projects to ensure all regulatory requirements are met throughout the development process
- Actively collaborate with clinical operations to develop documentation to be submitted to regulatory authorities and ethics committees for authorization of clinical studies
- Conduct periodic reporting and other activities required for the continued regulatory compliance of ongoing clinical studies
- Maintain current knowledge of EU, US, Canadian, and international regulations, guidance, and standards applicable to company products
- Create and coordinate product technical files, design dossiers, and design history files
- Interact with regulatory agencies such as the FDA, Health Canada, and EU notified bodies as required for the processing of submissions, regulatory reports, and any other regulatory actions
- Compile and process materials for license renewals, updates, and registrations
- Assist with the implementation and maintenance of systems for tracking submissions, and changes thereof, sent to regulators and partners
- Review marketing material, labeling, and labels for compliance with regulatory requirements
- Actively participate in evaluation of regulatory compliance of changes to documents, products, processes, and test methods, and define the requirements for regulatory reporting of such changes
- Conduct post-market surveillance activities, including review of customer complaints, trend analysis, and reporting
- Ensure continued compliance to applicable privacy regulations for clinical and operational activities
- Participate in research of regulatory issues and disseminate regulatory information to production, QA, QC, engineering teams, and senior management as required

**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 are suited to our approach and possess these attributes:

- Either a bachelor of science or engineering degree
- A minimum of 3 years of relevant regulatory affairs experience, or equivalent combination of post-graduate education and experience
- Experience with Class II/III medical devices, IVDs, or pharmaceuticals
- In-depth working knowledge of European, US, and Canadian medical device regulatory requirements is an asset
- Knowledge of privacy regulations (e.g., GDPR, PIPEDA, etc.) is an asset
- Experience with design controls is an asset
- Excellent written and verbal communication
- Excellent technical documentation skills with proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook).
- Strong time management with a sense of urgency, agility, transparency, respect, and collaboration in a team setting

**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 engineers, biologists, and specialists in human factors, and clinical and regulatory affairs
- An engaged leadership team who believes in mentoring and growing employees' careers
- Supportive and fun colleagues with plenty of social events to encourage people connections
- And our employees think we are great too - check out Glassdoor to learn more

Thanks in advance f

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