Combination Product & Regulatory Compliance Specialist (m/f)

Data Science Jobs

Savski Marof, Croatia
On-site
Quality system for combination products
Regulatory change management process
Design change management
The Combination Product & Regulatory Compliance Specialist position at Data Science Jobs in Savski Marof, Croatia, focuses on managing quality systems for combination products and ensuring compliance with regulatory requirements. This role requires collaboration with various teams to assess design and regulatory changes while preparing necessary documentation for regulatory submissions

Job Summary

  • This role is deeply involved in the quality system for combination products and serves as the liaison between the site and Worldwide Safety and Regulatory (WSR) and Global Technology and Engineering (GTEL).
  • Responsibilities include performing design and regulatory impact assessments, preparing documentation for regulatory submissions, and maintaining the Design Development File for combination products.
  • The company offers hybrid work arrangements, organized transport, a strong education program, and opportunities for career enhancement and development.

Matching Summary

Match Score: 85

The Combination Product & Regulatory Compliance Specialist position at Data Science Jobs in Savski Marof, Croatia, focuses on managing quality systems for combination products and ensuring compliance with regulatory requirements. This role requires collaboration with various teams to assess design and regulatory changes while preparing necessary documentation for regulatory submissions.

Skills & Requirements

Must-have

  • Quality system for combination products
  • Regulatory Change Management Process
  • Design Change Management
  • Regulatory submissions
  • Design Development File maintenance

Nice-to-have

  • Collaborative work environment
  • Proactive communication
  • Continuous improvement mindset

Key Requirements

  • University degree in pharmacy, biology, biotechnology, chemistry or related
  • More than 2 years of experience in pharmaceutical or device company

Work Rights

Not specified

Tailored Resume

Cover Letter