Job Details

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.

Keys to Success:

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.
• Ethical conduct, integrity, and ability to maintain confidentiality of information.

Physical Requirements / Work Environment:

• Sit or stand for extended periods on the computer.
• Use of standard office equipment & Microsoft OS
• When onsite, exposure to manufacturing environments with noise, dust, and varying temperatures.
• Interaction with cross-functional and global teams.
• Adapt to changing priorities in a fast-paced environment.
• Travel domestically and internationally up to 10%.

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. As 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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