Job Description Summary
Use your expert knowledge of regulatory compliance, including cGMP and ISO 13485/9001, to drive innovation as a Senior Manager with the Regulatory Affairs team. Your expertise will support regulatory submissions for products that do not fall into standard regulations such as a medical device or drug. Your people skills will allow you to effectively manage a team of skilled professionals which you will collaborate with, mentor, and develop. As a member of the Regulatory Affairs team, you will oversee projects within your portfolio while ensuring alignment to overall strategic company goals. Your role is critical in protecting the quality and integrity of our products and preserving our customers' trust in STEMCELL.Job Description Duties and Responsibilities
Knowledge and Qualifications
- Develop, standardize, execute, and approve all regulatory documentation. associated with products in the assigned portfolio to meet compliance. requirements of appropriate global regulatory bodies
- Employ strong time management and prioritization skills to oversee progress of multiple cross-functional projects simultaneously
- Build strong relationships with team, internal collaborators, and external stakeholders like provincial, national, and global regulatory bodies
- Evaluate risks and provide case-specific recommendations for regulatory scenarios in a variety of global regions, including process improvements, recalls, and approving third party agreements
- Review and ratify facility registrations and renewals
- A minimum of 10 years of experience in the biotech industry or equivalent experience as a senior regulatory expert. Subject matter expert knowledge and implementation experience with ISO, GMP, FDA, and EU Standards and Directives are required for this role
- You will be more successful in this role if you have a science-related educational background, are familiar with Quality Assurance, and are proficient in writing and reviewing technical documents such as De Novos, 510(k), PMAs, Master Files, IVDR Technical Documentation
- Apply critical thinking, attention to detail, and problem solving skills to develop creative solutions for problems as they arise
- Employ effective time management, prioritization, and organization skills to support the needs of the Regulatory Affairs team
- Navigate ambiguity while balancing business priorities with compliance
This role requires being fully vaccinated against COVID-19 as per STEMCELL's vaccination policy, the current recommendations by local health authorities and as required by public health orders in place from time to time, including any COVID-19 boosters as recommended by local health authorities and as required by public health orders in place from time to time.
STEMCELL Technologies Inc. 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 with boosters) against COVID-19, as currently recommended or required by local health authorities and public health orders.
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