Product Safety Compliance Specialist

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October 10

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

🏈 Ohio – Remote

Although this job is listed in Ohio, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Thermo Fisher Scientific

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Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Responsible for global product compliance in all phases of the product lifecycle • Contribute as a core team member on New Product Development teams by identifying regulatory requirements and coordinating certification tests • Analyze changes to existing products, define regulatory impacts, and resolve gaps • Liaise with testing laboratories for product testing and certifications • Collaborate with Quality, Engineering, and other cross-functions in support of Post-Market Surveillance investigations • Engage with regulatory agencies to register products and manage issues • Research industry methodologies and trends in regulatory compliance for improvements • Develop, monitor, and improve internal processes and tracking of metrics

🎯 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 • Functional understanding of manufacturing processes and product engineering change controls • Knowledge of international regulations and standards (e.g., ISO 9001, ISO 13485)

🏖️ Benefits

• competitive remuneration • annual incentive plan bonus • healthcare • range of employee benefits • innovative, forward-thinking organization • outstanding career and development prospects • exciting company culture that stands for integrity, intensity, involvement, and innovation