MedTech Regulatory Specialist - Global Submissions

Vita Global Sciences, a Kelly Company; Raynham (MA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Full benefits

Medical insurance

401K

Job summary

Kelly Science and Clinical FSP is seeking a Regulatory Specialist for a long-term engagement with a Global MedTech client. The role is full-time with benefits and is part of our FSP division, a managed solution within Kelly Services, Inc.

Responsibilities include providing independent regulatory guidance, leading licenses and registrations, ensuring compliance, preparing and submitting regulatory documents, and supporting audits. Collaboration across product development teams is essential.

Qualifications

• Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Inclusive of site transfer activities
• Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
• Defines data and information needed for regulatory approvals.
• Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
• Provide Regulatory Affairs support during internal and external audits.
• Plans schedules for regulatory deliverables on a project and monitors project through completion.
• Assists in the development of best practices for Regulatory Affairs processes.
• Represents Regulatory Affairs on cross-functional project teams.
• Partners with other functions to define and obtain data to assist with regulatory submissions.

Responsibilities

• Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Inclusive of site transfer activities
• Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
• Defines data and information needed for regulatory approvals.
• Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
• Provide Regulatory Affairs support during internal and external audits.
• Plans schedules for regulatory deliverables on a project and monitors project through completion.
• Assists in the development of best practices for Regulatory Affairs processes.
• Represents Regulatory Affairs on cross-functional project teams.
• Partners with other functions to define and obtain data to assist with regulatory submissions.

Job description

Kelly Science and Clinical FSP is seeking a Regulatory Specialist for a long-term engagement with a Global MedTech client. The role is full-time with benefits and is part of our FSP division, a managed solution within Kelly Services, Inc.

Responsibilities include providing independent regulatory guidance, leading licenses and registrations, ensuring compliance, preparing and submitting regulatory documents, and supporting audits. Collaboration across product development teams is essential.