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Medical Device, Quality/Risk Management, Regulatory Compliance
The Senior Specialist, Regulatory Affairs role at STEMCELL assists in the development and implementation of strategies to meet compliance to applicable regulations. It gives the opportunity to exercise independent judgment in evaluating complex problems and applying current methodologies and practices to resolve identified issues. STEMCELL is a dynamic workplace that pursues cutting edge technologies and practices which translates to this role managing complex sources of data that require in-depth critical thinking and reviewing the impact to the department and organization.
Duties and Responsibilities
Identify, interpret and apply global regulations applicable to STEMCELL’s products and processes
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies
Build processes, policies and practices to support regulatory compliance for medical devices
Lead project teams as the compliance representative to assess requirements, and develop and execute plans to support corporate initiatives
Lead in preparation and review of regulatory documentation and submissions to regulatory bodies including but not limited to Technical Files, Master Files, Site registrations, 510(k)s and risk analysis impact determinations to products
Conduct documentation review and approval to meet importation/exportation requirements for raw materials and finished products
In collaboration with Supply Chain, ensure timely resolution to compliance issues relating to the global transport of STEMCELL products
Create and lead training initiatives specific to quality and regulatory
Conduct internal and external audits to measure compliance to relevant standards, directives, regulations and policies.
Prepare, review and implement procedures and processes across the organization
Identify and evaluate and fill gaps related to compliance that cause risk to the business and regulatory certifications
Provide leadership and guidance to all staff as related to quality and regulatory practices
Education: Master’s or Bachelor’s Degree or Technical Diploma in relevant field.
Experience: 7-10 years’ experience in Regulatory Affairs and/or Quality Assurance in the biotech industry or equivalent.
Specialized knowledge: Knowledge of country specific regulatory requirements (e.g., cGMP 820s, ISO 13485 / 9001, FDA, Health Canada, European IVD device regulations, etc.) is a requirement. Experience with preparation of regulatory documentation such as a MF, IND, DHF, CMC is an asset. Strong knowledge in Design Control is a requirement.
Skills: Proven ability to coordinate and execute responsibilities relating to Regulatory Affairs. Excellent technical and scientific report writing and strong ability to understand and analyze technical documents, processes, regulations, industry standards, procedures and processes. Excellent communication skills.
Abilities: Demonstrated ability in project management and time management to ensure completion of tasks on a priority basis. Exercises judgment within undefined practices and procedures that may be incomplete or complex.
Other characteristics such as personal characteristics: Comfortable making presentations before groups; ability to question and not always be satisfied with the status quo; capability to balance compliance with business; willingness to learn and assume new responsibilities; good interpersonal skills; self motivated and independent work ethic; ability to handle multiple tasks in a fast paced environment.
Internal Number: R0002903
About STEMCELL Technologies Inc.
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.