Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description This site-based role is a temporary assignment for 16-18 months through July 2026. Benefits are included in this opportunity. Talent must live near the Ottawa site to be on-site 5 days/week. As a Compliance Specialist II - Regulatory Affairs, you will be responsible for the following tasks: Take part in all aspects of the Regulatory job function, which involves reviewing items/products for onboarding, addressing specific product inquiries, and tracking team performance. Apply internal screening processes to perform daily comprehensive regulatory reviews of new products. Ensure product compliance with applicable federal, state, and international regulations, including TDG, CSA, and Canadian medical device regulations, NHP regulations, etc. Assist with customer order approvals, including restricted components as needed. Maintain required regulatory permits and licenses such as 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 Compliance, and Supply Chain Departments as required. Train collaborators, customers, partners, and team members on new regulations. Assist with compliance audits, both internal and external. Prepare various regulatory compliance reports for submission to government agencies. Participate in Regulatory Group projects, PPI-Teams, and system-application improvement initiatives. Develop Work Instructions for core Regulatory functions and update existing Standard Operating Procedures (SOPs) as needed. Work with internal and external departments to facilitate problem resolution. Qualifications and Requirements: The ideal candidate for the Compliance Specialist II - Regulatory Affairs role will possess the following qualifications: Bachelor's degree in a related field or equivalent work experience. 3+ proven experience in regulatory affairs, ideally within the medical device or pharmaceutical industry. Strong understanding of federal, state, and international regulations. Outstanding attention to detail and ability to perform comprehensive regulatory reviews. Demonstrate ability to maintain regulatory permits and licenses. Strong interpersonal skills, both written and verbal, with the ability to provide training to collaborators. Ability to balance multiple projects and priorities simultaneously. Strong problem-solving skills and the ability to work collaboratively with various departments. Proficiency in preparing regulatory compliance reports and performing regulatory surveillance. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled 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, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
