Compliance Specialist (Regulatory)

Compliance Specialist I (Regulatory)

How will you make an impact?

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

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 onboarding with a particular focus on compliance with TDG, CSA, Medical Device Regulations, CFIA, Office of Controlled Substances, CEPA, Natural Health Products, WHIMS, etc. You will maintain required government licenses and registrations as needed.

Responsibilities:

• Participate in all aspects of the Regulatory job function, e.g. items/products review for onboarding, respond to specialized product questions, maintain KPI and team metrics, etc.
• Perform daily comprehensive regulatory reviews on new product applicability utilizing internal screening processes.
• Ensure product compliance to applicable federal, state and international regulations, including TDG, CSA, Canadian medical device regulations. NHP regulations etc.
• Maintain required regulatory permits and licenses (Precursor A & B, Restricted Components, Controlled Goods (CGP), Medical Device Licenses, Medical Device Establishment Licence, NHP Site Licence, etc.).
• Perform regulatory surveillance for new or changing regulations with federal agencies.
• Assist the Distribution Center, Customs and Supply Chain Departments as required.
• Serve as customer “technical contact” for internal and external inquires.
• Provide training on new regulations to applicable stakeholders.
• Assist with compliance audits, internal and external audits.
• Prepare various regulatory compliance reports for submission to Government agencies.
• Participate in Regulatory Group projects, PPI- Teams and system-application improvement initiatives and compliance projects.
• Create Work Instructions for core Regulatory functions and update existing Standard Operating Procedures (SOPs) as needed.
• Work with internal & external departments to facilitate problem resolution.

How will you get there?

Requirements:

• Bachelor’s Degree in Science (or other related program) or College Diploma in a science or lab-related field (Chemistry, Biology, Medical/Pharma).
• 3-5 years experience working within a regulatory compliance framework/ in industrial or health/ clinical fields.
• Applied experience in Canadian regulations including TDG, CSA, Medical Device, NHP, CEPA, WHIMS, GHS, CFIA, Controlled Substances.
• Ability to understand and interpret regulations and update compliance activities based on this information.
• Experience with process mapping, root cause analysis, and corrective action.
• Strong analytical, interpersonal skills, problem-solving and decision-making skills.
• Ability to work well under time constraints and deadlines.
• Outstanding organizational skills.
• Ability to retain large amounts of complicated information and apply it as needed.
• Capable of working with minimum supervision
• Ability to work in a fast-paced organization
• Ability to work collaboratively with others - team-oriented.
• Excellent oral and written communication skills.
• Advanced knowledge of MS Office software with a particular focus on MS Excel, PowerPoint and Visio.

At Thermo Fisher Scientific, each one of our 75,000 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.