Group Regulatory Affairs Specialist Class Ii (m/f/d)

Ontex

Grosspostwitz, Germany
On-site
Regulatory frameworks and strategy
Product development and registration
Postapproval/postmarket
Researches and determines requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities

Job Summary

  • Researches and determines requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities.
  • Works with cross-functional teams for interactions with regulatory authorities.
  • A permanent employment contract in an future-proof company bound by collective agreements.

Matching Summary

Researches and determines requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities.

Skills & Requirements

Must-have

  • Regulatory Frameworks and Strategy
  • Product Development and Registration
  • Postapproval/Postmarket
  • Scientific and Health Concepts
  • US and Canada regulations
  • quality management systems

Nice-to-have

  • creative and innovative internal advice
  • strong relationships across departments
  • stakeholder groups to help shape decisions
  • evolving regulatory information systems

Key Requirements

  • Master’s degree in science
  • Minimum of 3 years experience
  • Experience in 510k submission
  • Fluent in English

Work Rights

Not specified

Tailored Resume

Cover Letter