[Remote] Product Safety Compliance Specialist at Thermo Fisher Scientific

North Carolina, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

High school diploma or equivalent required
Suggested bachelor's degree in regulatory, project management, or STEM-related field
3+ years experience in quality, compliance, or verification roles
Exposure to manufacturing environments, especially laboratory or medical devices
Involvement with product development and sustaining engineering activities, covering the entire product lifecycle
Working within Product Lifecycle Management systems to review and approve design drawings, specifications, and other technical documents
Participating in post-market surveillance activities such as investigations, root causes, and CAPA
Applying functional knowledge and risk-based analysis in risk assessment activities, such as ISO 12100 or ISO 14971
Strong interpersonal and project management skills
Detail-orientation, analytical reasoning abilities, investigational curiosity, and systems thinking
Functional understanding of manufacturing processes and product engineering change controls
Awareness of international regulations, standards, and requirements for safety, EMC, wireless, environmental, and circular economy topics
Exceptional written and verbal communication skills

Responsibilities

Global product compliance in all phases of the product lifecycle
Ensuring that medical and laboratory devices adhere to relevant laws, regulations, standards, and internal policies
Preventing non-compliances, managing risks, and resolving issues when found
Contributing as a core team member on New Product Development teams by identifying regulatory requirements, coordinating external certification tests, and publishing technical documentation for global markets
Analyzing changes to existing products, defining regulatory impacts, and resolving gaps through interaction with testing laboratories and revision of technical documentation
Liaising with testing laboratories for product testing, certifications, and site inspections
Collaborating with Quality, Engineering, and other cross-functions in support of Post-Market Surveillance investigations, field activities, reporting, and initiating product improvements
Engaging with regulatory agencies and authorities to register products, resolve questions, and manage issues
Researching industry standard methodologies and emerging trends in regulatory compliance to implement regulation changes and improvements
Developing, monitoring, and improving internal processes, control systems, and tracking of metrics
Performing all job duties per policies and procedures, in a safe and ethical manner

Skills

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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