Senior Manager, Compliance
About the role
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 are now preparing for our upcoming commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.
As a senior member of the Quality Assurance (QA) and Regulatory Affairs (RA) team, the Senior Manager, Compliance will be responsible for supporting Kardium’s quality system engagements to ensure compliance with worldwide medical device regulations. The position reports to the Director, Compliance and Quality Improvement.
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Responsibilities:
Supplier Management:
- In collaboration with Supply Chain, manage the system for qualifying and monitoring suppliers as per the established requirements
- Prepare and maintain the supplier audit schedule and prepare audit assignments
- Provide audit training and guidance to internal auditors and audit teams
- Plan, conduct and document supplier quality system audits, as needed
- Perform supplier quality data analysis and trending
Internal audit program
- Prepare and maintain the internal audit schedule, and prepare audit assignments
- Provide audit training to internal auditors and audit teams
- Plan, conduct and document internal quality system audits, as needed
- Ensure internal audit follow-up activities are performed
- Provide trending information for Management Review
Clinical QA:
- Collaborate with Clinical Operations staff to ensure the regulatory compliance of clinical investigations
- Review clinical procedures, documents, plans and reports to ensure compliance with Good Clinical Practice
- Assist in the qualification and monitoring of clinical suppliers
CAPA and Quality Improvements:
- Manage the Corrective and Preventive Action (CAPA) program to ensure the regulatory compliance of CAPAs
- Review and approve CAPA plans and reports, as needed
- Provide training on CAPA processes and investigation techniques
- Assist in identifying quality improvements
- Perform quality improvement projects, as needed
External Inspections and Other Responsibilities:
- Assist in the preparation for, and the hosting of, external audits and regulatory inspections
- Perform any other QA tasks as required
Education and Experience
-
Bachelor’s degree in engineering, natural sciences or similar field. Master’s degree preferred
-
Minimum of 7+ years QA experience in a manufacturing environment, including QA managerial experience
-
Strong, working knowledge of worldwide cGMPs, regulatory requirements, standards, and quality management systems for medical devices:
-
US FDA (21 CFR parts 820, 801, 803, 806)
-
European MDR
-
ISO 13485 / MDSAP
-
Good working knowledge of quality improvement tools. Certification in Quality Improvement or lean techniques an asset
-
Experience with electronic document and record management systems
-
Experience working with regulating authorities (e.g., US Food and Drug Administration) or regulatory bodies (e.g., registrar; certifier) an asset
Skills and Attributes:
- Certified ISO 13485 lead auditor with experience as an auditor in the medical devices, in-vitro diagnostics, or pharmaceutical industry
- Supplier QMS engagements may require travel in Canada, USA, and globally on short notice
- Strong analytical skills and critical thinking
- Effective written & verbal communication and technical documentation skills
- Able to operate independently with minimal direction
- Detail-oriented
- Excellent interpersonal skills
- Flexible and adaptable to take on additional responsibilities as appropriate
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.
- $180,000-$210,000 (CAD Annually)
Your Benefits & Well-being
- 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.
- Family building – we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment.
- Career progression and learning support.
- Professional membership support.
Life at Kardium
What makes us a great place to work?
- Our Purpose
- Our People
- 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!
Senior Manager, Compliance
About the role
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 are now preparing for our upcoming commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.
As a senior member of the Quality Assurance (QA) and Regulatory Affairs (RA) team, the Senior Manager, Compliance will be responsible for supporting Kardium’s quality system engagements to ensure compliance with worldwide medical device regulations. The position reports to the Director, Compliance and Quality Improvement.
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Responsibilities:
Supplier Management:
- In collaboration with Supply Chain, manage the system for qualifying and monitoring suppliers as per the established requirements
- Prepare and maintain the supplier audit schedule and prepare audit assignments
- Provide audit training and guidance to internal auditors and audit teams
- Plan, conduct and document supplier quality system audits, as needed
- Perform supplier quality data analysis and trending
Internal audit program
- Prepare and maintain the internal audit schedule, and prepare audit assignments
- Provide audit training to internal auditors and audit teams
- Plan, conduct and document internal quality system audits, as needed
- Ensure internal audit follow-up activities are performed
- Provide trending information for Management Review
Clinical QA:
- Collaborate with Clinical Operations staff to ensure the regulatory compliance of clinical investigations
- Review clinical procedures, documents, plans and reports to ensure compliance with Good Clinical Practice
- Assist in the qualification and monitoring of clinical suppliers
CAPA and Quality Improvements:
- Manage the Corrective and Preventive Action (CAPA) program to ensure the regulatory compliance of CAPAs
- Review and approve CAPA plans and reports, as needed
- Provide training on CAPA processes and investigation techniques
- Assist in identifying quality improvements
- Perform quality improvement projects, as needed
External Inspections and Other Responsibilities:
- Assist in the preparation for, and the hosting of, external audits and regulatory inspections
- Perform any other QA tasks as required
Education and Experience
-
Bachelor’s degree in engineering, natural sciences or similar field. Master’s degree preferred
-
Minimum of 7+ years QA experience in a manufacturing environment, including QA managerial experience
-
Strong, working knowledge of worldwide cGMPs, regulatory requirements, standards, and quality management systems for medical devices:
-
US FDA (21 CFR parts 820, 801, 803, 806)
-
European MDR
-
ISO 13485 / MDSAP
-
Good working knowledge of quality improvement tools. Certification in Quality Improvement or lean techniques an asset
-
Experience with electronic document and record management systems
-
Experience working with regulating authorities (e.g., US Food and Drug Administration) or regulatory bodies (e.g., registrar; certifier) an asset
Skills and Attributes:
- Certified ISO 13485 lead auditor with experience as an auditor in the medical devices, in-vitro diagnostics, or pharmaceutical industry
- Supplier QMS engagements may require travel in Canada, USA, and globally on short notice
- Strong analytical skills and critical thinking
- Effective written & verbal communication and technical documentation skills
- Able to operate independently with minimal direction
- Detail-oriented
- Excellent interpersonal skills
- Flexible and adaptable to take on additional responsibilities as appropriate
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.
- $180,000-$210,000 (CAD Annually)
Your Benefits & Well-being
- 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.
- Family building – we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment.
- Career progression and learning support.
- Professional membership support.
Life at Kardium
What makes us a great place to work?
- Our Purpose
- Our People
- 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!