How will you make an impact?
With 70000 extraordinary minds on our global team, each one of us at Thermo Fisher has an important story to tell. Whether we're helping customers to fight disease, making sure our air is clean, or solving cold cases, our stories involve thousands of important projects that improve millions of lives. Our dedicated sales professionals are laser focused on delivering our customer value proposition—accelerating innovation and enhancing productivity. With talented managers and inspiring coworkers to support you, you'll find the resources and opportunities to make significant contributions to the world.
What you will do?
As a key member of the Quality and Regulatory Team, you will provide regulatory support to various departments as it relates to the sale of regulated products. You will perform daily comprehensive regulatory reviews for new product introduction with particular focus on compliance with TDG, CSA, medical devices, CFIA, Office of Controlled Substances, CEPA, Health Canada, WHIMS, etc. You will maintain required government licenses and registrations as needed.
- Review newly activated items for regulatory compliance to applicable federal regulation
- Perform daily comprehensive regulatory reviews on new product applicability, utilizing internal screening processes against federal, state and international regulations
- Maintain CFIA permits/licenses
- Perform regulatory surveillance for new or changing regulations with federal agencies
- Assist Customs Department with issues at border by escalation to government departments
- Become “point of contact” for specialized product questions (albumin, sera, human/animal derived products)
- Serve as customer “technical contact” for internal and external inquires
- Lead regulatory projects with management supervision
- Perform training for new regulations to applicable stakeholders
- Assist Manager of Quality/Regulatory with other related departmental projects/issues
- Assist with compliance audits
- Develop compliance report
- Maintain KPI Regulatory Team Metrics
- Participate in Regulatory Group projects, PPI- Teams and system-application improvement initiatives and compliance projects
- Review items for regulatory compliance to applicable federal regulations – TDG, CSA approval, registrations with Health Canada for medical devices, D.I.N. or N.H.P. registrations
- Ensure items are not restricted for sale through either government regulation or Fisher Scientific policy – block items accordingly if required
- Keep abreast of new federal regulations and implement as required
- Maintain required government licenses (applications & applicable fees) – Precursor A & B, Restricted Components, Controlled Goods (CGP), MOE/HWIN registration, CANUTEC registration
- Maintain required import permits where required
- Work with internal & external departments to facilitate problem resolution when required
How will you get there?
- Knowledge of regulations as they pertain to the Scientific & Laboratory Industry
- Familiar with Canadian regulations including TDG, CSA, Medical Device, CEPA, WHIMS, GHS, CFIA, Controlled Substances.
- Experience with process mapping, root cause analysis, and corrective action
- Strong analytical, interpersonal skills, problem solving and decision-making skills
- Strong interpersonal, problem solving and decision-making skills
- Ability to work well under time constraints and deadlines
- Excellent communication and listening skills
- Outstanding organizational skills
- Capable of working with minimum supervision
- Team oriented, professional
- Ability to work in a fast paced organization
- Advanced knowledge of MS Office software with a particular focus on MS Excel and PowerPoint
- Bachelor Degree in Science (or other related program) or College Diploma in a science or lab related field (Chemistry, Biology, Medical/Pharma)
- 3 - 5 years of experience working within a regulatory compliance framework in industrial or hospital fields
- Ability to understand and interpret regulations and evolve compliance activities
- Familiar with Canadian regulations including TDG, CSA, Medical Device, CEPA, WHIMS, DLS, GHS, CFIA, Controlled Substances.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an equal opportunity employer and is committed to the principle of diversity and is particularly interested in receiving applications from a broad spectrum of people. Accommodations for job applicants with disabilities are available upon request.
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