Job Description Summary

Are you ready to take on a pivotal role as a Regulatory Affairs Manager?

Join STEMCELL Technologies, a world-leading company in the life sciences industry, and work alongside renowned diagnostic partners. As our Regulatory Affairs Manager, you will have the opportunity to exchange ideas and have a seat at the table, collaborating with industry experts and engaging with regulatory bodies such as the FDA. If you have a passion for regulatory compliance and a desire to make a significant impact in the field of medical devices, this role is perfect for you.

Job Description

Duties and Responsibilities

• Act as the primary point of contact for devices, taking responsibility for deliverables related to pre-market activities within initial design and development

• Collaborate with regional regulatory bodies and third party representatives to ensure compliance and successful market approvals

• Contribute to the design and development of medical devices and in vitro diagnostic (IVD) products through activities such as risk management, compliance to applicable standards, developing product and user requirements, and implementing processes compliant with regulatory requirements

• Compile regulatory submissions for the US, EU, Canada, and other regions, with 5-7 years of pre-market device experience

• Work with electromechanical devices, balancing compliance requirements with business needs

Knowledge and Qualifications

• A minimum of one year managing a team in a Regulatory or Quality team

• At least 5 years of pre-market experience, where working with novel devices is an asset

• Previous experience contributing to the design and development of a medical device or IVD product

• Familiarity with regulatory compliance in the Asian market, with a preference for medical device expertise

• Relevant regulatory certifications such as RAPS, RAC, or ASQ certification would be an asset

​

#LI-Hybrid #Nonbench #LI-ML1

STEMCELL Technologies is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.

This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.

STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada’s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.

As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.

NOTE: STEMCELL’s vaccination policy requires that all candidates for this role be fully vaccinated against COVID-19 (including boosters), as currently recommended or required by local health authorities and public health orders, unless an exemption from this policy is approved through our accommodation request process.

To apply, please select the “Apply” button below. You will then be directed to a login screen asking you to set up an account, which is required to apply.​​