Regulatory Affairs Specialist III
Thermo Fisher Scientific
- Asheville, NC
- Permanent
- Full-time
- Participates as a core team member on New Product Development teams, providing regulatory requirements, management of compliance verification tests, and publishing of technical documentation for global markets.
- Analyzes product changes, defines regulatory impacts, and resolves gaps through interaction with testing laboratories and revision of technical documentation.
- Collaborates with Quality, Engineering, and other cross-functions in support of Post Market Surveillance activities, investigations, and product improvements.
- Engages with regulatory agencies and authorities to resolve questions or issues.
- Collaborates with NRTLs and other testing laboratories for product testing, certifications, and site inspections.
- Researches industry standard methodologies and emerging trends in regulatory compliance, and drives improvements to existing database.
- Creates, monitors, and improves processes, control systems and tracking of metrics.
- Performs all job duties in a safe and ethical manner, and obeys all safety policies and procedures.
- 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: investigations, root causes, CAPA.
- Applying functional knowledge and risk-based analysis in risk assessment activities, such as ISO 12100 or ISO 14971.
- Exposure to manufacturing environments, especially laboratory or medical devices.
- Strong organizational and project management skills, with the ability to handle multiple tasks, and prioritize effectively.
- Proven detail-orientation, analytical reasoning abilities, and systems thinking.
- Works well in dynamic and cross functional team environments.
- 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. e.g. IEC 61010-1 and IEC 61326-1.
- Exceptional written and verbal communication skills, with the ability to effectively communicate complex compliance concepts to diverse collaborators.
- Ethical conduct, integrity, and ability to maintain confidentiality of information.