Senior Regulatory Affairs Specialist
Job Description SummaryJoin the largest biotechnology company in Canada and utilize your expertise to disseminate the evolving landscape of regulatory requirements. As a Senior Regulatory Affairs Specialist, your knowledge and background with medical devices will guide the development of STEMCELL’s products to ensure they continue supporting various stages of life science research. You are a quality-driven individual, with an immense attention to detail to ensure every document and box is checked appropriately before submissions to drive our global reach.
Duties and Responsibilities
Work with the development and pre-market submissions of In Vitro Diagnostics (IVD) and Medical Devices
Identify, interpret and apply global regulations applicable to STEMCELL’s products, building processes, policies and practices to establish regulatory compliance
Continuously grow regulatory knowledge of domestic and international regulations, guidelines, and standards while applying appropriate implementation strategies
Mentor project teams as the compliance representative to assess requirements, and develop and execute plans to guide corporate initiatives
Cross functional collaboration, communication and influence is a key part of the role
Knowledge and Qualifications
Bachelor's degree or diploma in a relevant field with a minimum of 3 years of experience in a regulated industry (e.g. biotechnology, medical devices, regulatory affairs or quality assurance)
Understanding of ISO, GMP, FDA, EU Regulations, Standards and Directives
Key contributor for writing sections of Regulatory Submissions such as De Novos, 510(k), PMAs, Master Files, IVDR Technical Documentation
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 significant career development opportunities.
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Create an account by selecting the create account button. You will then be asked for your email and to create a password. Your Password must be eight characters long, contain at least one special character, one capital letter, and a number.Once you have created your password you will be asked to upload your resume. Uploading your resume will provide the ability to auto-populate your application with information from your resume. If you prefer to manually complete all of the fields in the application you can do this by clicking next. You can upload your cover letter as an attachment in the attachments screen. Thank you for your interest in STEMCELL!