Senior Regulatory Affairs Specialist

Summary

Join our team as a Senior Regulatory Affairs Specialist at STEMCELL Technologies!

Are you passionate about making a significant impact on the world of life sciences? Do you thrive in a dynamic, fast-paced environment where your expertise in regulatory affairs can drive innovation and ensure compliance? If so, we have an exciting opportunity for you! We are seeking a talented and experienced Senior Regulatory Affairs professional to join our team and contribute to our mission of advancing scientific discovery and advancing life science research.

Duties and Responsibilities

• Compile pre-market submissions, including pre-submissions, 510(k), De novo, and IVDR Technical Documentation as necessary
• Collaborate with cross-functional teams to provide regulatory inputs during the design and development phase of our devices
• Provide inputs to other regulatory processes, including change control, monitoring and implementation of external standards, design control process, pre-market submission process, and labelling creation/updates
• Build partnerships, internally and externally, to provide routine updates and ensure compliance with regulatory requirements
• Be a valuable member of our risk management team, contributing from a regulatory perspective to risk assessment exercises and documents

Knowledge And Qualifications

• Proven experience in compiling and submitting pre-market regulatory submissions, such as 510(k), De novo, and IVDR Technical Documentation
• Ability and eligibility to participate and travel as a regulatory representative in international external audits
• Strong knowledge of global regulatory requirements and standards, including FDA regulations (e.g., 21 CFR Part 820), EU MDR/IVDR, and other international regulations
• A minimum of 3 years of experience in regulatory affairs within the medical device or life sciences industry
• A Bachelor's or Master's degree in a relevant scientific or engineering field

#Nonbench

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.

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