[Remote] Product Safety Compliance Specialist at Thermo Fisher Scientific

North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Laboratory EquipmentIndustries

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, with the ability to handle multiple tasks and prioritize effectively
Detail-orientation, analytical reasoning abilities, investigational curiosity, and systems thinking
Self-starter who works well in fast-paced and cross-functional team environments
Functional understanding of manufacturing processes and product engineering change controls (e.g., ISO 9001, ISO 13485)
Awareness of international regulations, standards, and requirements for safety, EMC, wireless, environmental, and circular economy topics (e.g., LVD, RED, RoHS, REACH, 61010-1, 61326-1, 62304-1)
Exceptional written and verbal communication skills, with the ability to effectively communicate complex compliance concepts to diverse collaborators
Ethical mindset

Responsibilities

Contribute 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
Analyze changes to existing products, define regulatory impacts, and resolve gaps through interaction with testing laboratories and revision of technical documentation
Liaise with testing laboratories for product testing, certifications, and site inspections
Collaborate with Quality, Engineering, and other cross-functions in support of Post-Market Surveillance investigations, field activities, reporting, and initiating product improvements
Engage with regulatory agencies and authorities to register products, resolve questions, and manage issues
Research industry standard methodologies and emerging trends in regulatory compliance to implement regulation changes and improvements
Develop, monitor, and improve internal processes, control systems, and tracking of metrics
Perform all job duties per policies and procedures, in a safe and ethical manner

Skills

Key technologies and capabilities for this role

Regulatory ComplianceGMPProduct CertificationTechnical DocumentationPost-Market SurveillanceRisk ManagementNew Product DevelopmentCross-functional Collaboration

Questions & Answers

Common questions about this position

What is the work arrangement or location for this role?

The role prefers locations at or near manufacturing sites in Marietta, OH, or Asheville, NC, and follows standard office hours of 40 hours per week.

What education and experience are required for this position?

A high school diploma or equivalent is required, with a suggested bachelor's degree in regulatory, project management, or STEM-related field, plus 3+ years of experience in quality, compliance, or verification roles.

What salary or compensation does this role offer?

This information is not specified in the job description.

What is the company culture like at Thermo Fisher Scientific?

The company emphasizes meaningful work that positively impacts the world on a global scale, enabling customers to make the world healthier, cleaner, and safer, while providing resources for individual career goals.

What makes a strong candidate for this Product Safety Compliance Specialist role?

Strong candidates have exposure to manufacturing environments in laboratory or medical devices, involvement in product development and sustaining engineering across the product lifecycle, and experience with Product Lifecycle Management systems.

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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