Product Safety Compliance Specialist

This job is with Thermo Fisher Scientific, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Work Schedule
Standard Office Hours (40/wk)  Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information   We are seeking a professional to join our Laboratory Equipment Division, with preferred locations at or near our manufacturing sites in Marietta, OH, or Asheville, NC.

Discover Impactful Work:  Our Regulatory Specialist role is responsible for global product compliance in all phases of the product lifecycle. The ideal candidate ensures that our medical and laboratory devices adhere to relevant laws, regulations, standards, and internal policies. Our work focuses on preventing non-compliances, managing risks, and resolving issues when found.

A day in the Life:
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.

Education    High school diploma or equivalent required.
Suggested bachelor's degree in regulatory, project management, or STEM-related field.

Experience    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.

Knowledge, Skills, Abilities    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, etc.
Exceptional written and verbal communication skills, with the ability to effectively communicate complex compliance concepts to diverse collaborators.
Ethica…