Director, Regulatory Affairs
About the role
Job Title: Director, Regulatory Affairs Location: Greater Vancouver, BC
Industry: In Vitro Diagnostics (IVD) / MedTech
Type: Full-Time | On-site
Reports To: Executive Leadership
Salary Range: $125,000 to $135,000
About The Company Our client is a growing IVD company recognized for advancing diagnostic accuracy and regulatory excellence. Headquartered in Greater Vancouver, the company is expanding globally with a strong focus on quality and compliance.
Position Overview
The Director, RA will lead regulatory strategy and team activities for IVD products across global markets, ensuring successful submissions and ongoing compliance with international standards. This role includes mentoring staff and aligning regulatory efforts with R&D, operations, and commercial functions.
Key Responsibilities
- Lead regulatory strategy and team for IVD products across global markets.
- Direct submissions and serve as primary liaison with FDA, Health Canada, and EU Notified Bodies.
- Ensure QMS compliance with ISO 13485, MDSAP, and international standards.
- Provide clinical oversight support as required.
- Provide customer support as required.
- Monitor evolving regulations and update policies and processes as needed.
Qualifications
- MSc in a scientific or engineering field, or equivalent experience.
- 8+ years IVD regulatory experience with FDA, Health Canada, and EU IVDR.
- Proven expertise in global submissions and compliance programs.
- Demonstrated leadership managing teams in a mid-sized company.
- Strong cross-functional collaboration skills.
- Must have legal authority to work in Canada.
Why Join
This is an opportunity to lead regulatory affairs in a dynamic IVD company with an innovative pipeline and supportive leadership, while making a global impact on diagnostic healthcare.
#TSSHP LI-TS1
Job Posting ID: #16712441
About TalentSphere Staffing Solutions
Since 2013, TalentSphere Staffing Solutions has been a trusted partner for businesses across Canada and the US, providing top-tier recruitment and staffing services. With over two decades of industry expertise, our team of specialized recruiters is dedicated to connecting leading organizations with exceptional talent.
Our proven track record of successful placements speaks to our deep understanding of the industries we serve. We offer customized solutions that meet the unique needs of each client, whether it's executive search, permanent placement, or contract staffing. By leveraging our extensive network and market insights, we consistently deliver high-quality candidates who not only meet technical requirements but also align with company culture.
At TalentSphere, we believe in building lasting relationships and providing an unparalleled level of service, ensuring both clients and candidates find the perfect fit. With over 60 remote professionals working across Canada, we offer the agility and reach to support businesses of all sizes, from startups to global enterprises.
Discover how TalentSphere can help elevate your business by connecting you with the talent you need to succeed.
Director, Regulatory Affairs
About the role
Job Title: Director, Regulatory Affairs Location: Greater Vancouver, BC
Industry: In Vitro Diagnostics (IVD) / MedTech
Type: Full-Time | On-site
Reports To: Executive Leadership
Salary Range: $125,000 to $135,000
About The Company Our client is a growing IVD company recognized for advancing diagnostic accuracy and regulatory excellence. Headquartered in Greater Vancouver, the company is expanding globally with a strong focus on quality and compliance.
Position Overview
The Director, RA will lead regulatory strategy and team activities for IVD products across global markets, ensuring successful submissions and ongoing compliance with international standards. This role includes mentoring staff and aligning regulatory efforts with R&D, operations, and commercial functions.
Key Responsibilities
- Lead regulatory strategy and team for IVD products across global markets.
- Direct submissions and serve as primary liaison with FDA, Health Canada, and EU Notified Bodies.
- Ensure QMS compliance with ISO 13485, MDSAP, and international standards.
- Provide clinical oversight support as required.
- Provide customer support as required.
- Monitor evolving regulations and update policies and processes as needed.
Qualifications
- MSc in a scientific or engineering field, or equivalent experience.
- 8+ years IVD regulatory experience with FDA, Health Canada, and EU IVDR.
- Proven expertise in global submissions and compliance programs.
- Demonstrated leadership managing teams in a mid-sized company.
- Strong cross-functional collaboration skills.
- Must have legal authority to work in Canada.
Why Join
This is an opportunity to lead regulatory affairs in a dynamic IVD company with an innovative pipeline and supportive leadership, while making a global impact on diagnostic healthcare.
#TSSHP LI-TS1
Job Posting ID: #16712441
About TalentSphere Staffing Solutions
Since 2013, TalentSphere Staffing Solutions has been a trusted partner for businesses across Canada and the US, providing top-tier recruitment and staffing services. With over two decades of industry expertise, our team of specialized recruiters is dedicated to connecting leading organizations with exceptional talent.
Our proven track record of successful placements speaks to our deep understanding of the industries we serve. We offer customized solutions that meet the unique needs of each client, whether it's executive search, permanent placement, or contract staffing. By leveraging our extensive network and market insights, we consistently deliver high-quality candidates who not only meet technical requirements but also align with company culture.
At TalentSphere, we believe in building lasting relationships and providing an unparalleled level of service, ensuring both clients and candidates find the perfect fit. With over 60 remote professionals working across Canada, we offer the agility and reach to support businesses of all sizes, from startups to global enterprises.
Discover how TalentSphere can help elevate your business by connecting you with the talent you need to succeed.