Global Regulatory Affairs Lead — Cross-Functional Impact 12-mo

Generis Tek Inc; California; In loco; USD 100.000 - 112.000; Tempo pieno

Descrizione del lavoro

Generis Tek Inc in Santa Clara, CA is seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory requirements across franchises and international markets. The role emphasizes assessing regulatory changes, coordinating impact assessments, and driving implementation into quality systems and business operations.

The ideal candidate has 5-7 years in regulated medical device or pharmaceutical environments, strong project management, and stakeholder leadership to ensure

Competenze

• 5-7 years of experience in a highly regulated industry (medical device/pharma) in Regulatory Affairs/Operations/Compliance or related function.
• Strong understanding of international regulatory requirements and global compliance frameworks.
• Experience implementing regulatory requirements across cross-functional teams.
• Strong project management, organizational, and stakeholder management skills.
• Ability to work independently and drive initiatives with minimal oversight.
• Ability to drive issues to resolution and implement mitigations.
• Ability to handle multiple streams with timely execution.

Mansioni

• Lead pan-franchise implementation of emerging global regulatory requirements across international markets.
• Assess new or changing international regulations for business impact, implementation needs, risks, and timelines.
• Coordinate cross-functional gap assessments and implementation plans to embed regulatory requirements into quality systems, procedures, labeling, and operations.
• Partner with Regulatory Affairs, Quality, Labeling, Supply Chain, Legal, and affiliate teams to drive timely and compliant execution.
• Monitor implementation activities, identify risks, and drive issue resolution to support on-time compliance.
• Support audit readiness activities and participate in internal, external, and regulatory inspections as needed.
• Develop and maintain KPIs, dashboards, trackers, and governance reports to provide visibility into progress and risks.
• Lead change management activities for regulatory and procedural updates.

Conoscenze

Regulatory Affairs

Regulatory Compliance

Regulatory Operations

Quality Systems

Compliance

Project management

Stakeholder leadership

Descrizione del lavoro

Generis Tek Inc in Santa Clara, CA is seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory requirements across franchises and international markets. The role emphasizes assessing regulatory changes, coordinating impact assessments, and driving implementation into quality systems and business operations.

The ideal candidate has 5-7 years in regulated medical device or pharmaceutical environments, strong project management, and stakeholder leadership to ensure