Sr Regulatory Affairs Specialist
Thermo Fisher Scientific

Job Info

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Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

What we do?

Develops document package necessary to support product certifications and registrations for regulatory submissions and product listings with Competent Authorities and Notified Bodies, external and internal audits and inspections.

Creates and maintains product technical files in accordance with site policies to ensure compliance with legislation prior to product launch.

Communicates with R&D teams and other personnel (Marketing, Sourcing) to develop compliance plans for New Product Introduction.

Participates on product development teams, providing regulatory strategies, timelines, and direction.

Reviews and approves labeling, product manuals, and technical datasheets and other product material for regulatory compliance.

Liaises between the respective subject areas and 3rd Party regulatory agencies (Eurofins, BV, TUV, Notified Bodies, etc.) for product design changes.

Leads follow up audit and field action teams as necessary as well as support and help effectively handle any identified non-conformity, product liability incident or other post-market activities (e.g. CAPA, Safety Concern, issue assessments).

Provides support to Commercial Teams relative to local submissions, license renewal, annual registrations, and other compliance issues.

Drives product change assessments and define regulatory impact of product changes in global markets.

Participates in group, site, and 3rd party training events to stay informed and competent on the latest changes to regulatory procedures and standards.

Performs all job duties within the ISO 9001 Quality Management System and in a safe manner and obey all safety policies and procedures.

Performs as a Role Model Leader, acting in compliance with the Thermo Fisher Scientific Code of Ethics and the 4-I Values (Integrity, Intensity, Innovation, and Involvement)

How will you get here?

Education:

• Bachelor's degree preferred (Electrical, Mechanical, or Systems Engineering preferred degree); advanced degree a plus.
• Experience:
• 3 years related experience working in a manufacturing or highly technical field required. 5+ years preferred
• Strong experience with NRTL/regulatory submissions as well as negotiating requirements with Competent Authorities and Notified or Regulatory Bodies

Knowledge Skills:

• Strong Communication skills - able to communicate, written and oral, with both technical and non-technical colleagues
• Outstanding interpersonal skills to work on a multi-functional team and lead without authority.
• Ability to read and understand technical documents such as standards and regulations. Validated knowledge of the applicable safety standards and how to apply compliance solutions effectively.
• Resourcefulness and flexibility to prioritize, conduct, and handle time to meet project requirements.
• Confirmed problem solving, particularly around leading a new regulation requirements.
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends.

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