Combination Product & Regulatory Compliance Specialist (m/f)

Data Science Jobs

Savski Marof, Croatia
Not specified; yearly pyy increase + bonus based o...
Hybrid
Quality system for combination products
Design change management
Regulatory change management process
The job posting seeks a Combination Product & Regulatory Compliance Specialist for a hybrid position in Savski Marof, Croatia, primarily focused on managing quality systems for combination products while ensuring compliance with regulatory requirements. The role involves collaborating with various departments to assess design and regulatory changes, as well as preparing documentation for regulatory submissions

Job Summary

  • This role serves as the liaison between the site and Worldwide Safety and Regulatory teams to manage quality systems for combination products.
  • The specialist is responsible for performing design and regulatory impact assessments and preparing documentation for regulatory submissions.
  • Candidates must hold a university degree in pharmacy, biology, biotechnology, chemistry, or a related subject with over two years of industry experience.

Matching Summary

Match Score: 85

The job posting seeks a Combination Product & Regulatory Compliance Specialist for a hybrid position in Savski Marof, Croatia, primarily focused on managing quality systems for combination products while ensuring compliance with regulatory requirements. The role involves collaborating with various departments to assess design and regulatory changes, as well as preparing documentation for regulatory submissions.

Salary

Not specified; Yearly pay increase and bonus based on performance; Christmas, Easter and holiday bonus

Skills & Requirements

Must-have

  • Quality System for Combination Products
  • Design Change Management
  • Regulatory Change Management Process
  • Product Change Form (PCF) in PDM system
  • Market Impact Assessment (MIA)
  • BOH approval timelines

Nice-to-have

  • Problem solving skills
  • Analytical ability with scientific data
  • Collaborative team environment
  • Independent judgment execution
  • Hybrid work arrangements

Key Requirements

  • University degree in pharmacy, biology, biotechnology, chemistry or related subject
  • More than 2 years of experience in pharmaceutical or device company
  • Ability to maintain Registration and Design control documentation

Work Rights

Not specified

Tailored Resume

Cover Letter