Regulatory Affairs Specialist III - Asheville, United States - Thermo Fisher Scientific

Description

Job Description

Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you'll help solve some of the world's toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics.

We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.

Discover Impactful Work:
The Regulatory Specialist is accountable for global product compliance through design consultation, manufacturing, and post market support.

This role is responsible to carry out strategies, procedures, and practices, in collaboration with international Regulatory team members, R&D, Marketing, Quality, Operations, Service, and other functions.

This role supports integration of regulatory compliance requirements for laboratory and medical devices from product inception, and maintains compliance throughout the product lifecycle.

A day in the Life:

• 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.

Requirements

• STEM related Bachelor's degree or 4+ years of experience in product compliance, quality, regulatory affairs, or engineering.

Suggested Experience

• 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.

Knowledge, Skills, Abilities

• 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 and IEC
• 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.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us.

A one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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