The company:
The Regulatory Affairs specialist candidate will be based in Berlin will have the opportunity to provide regulatory support to the Director, Regulatory Affairs-Regional Regulatory Strategist, - EU & International.
Your tasks:
- Development and implementation of regulatory strategies for the company's products
- Preparation, submission and maintenance of national as well as international regulatory approvals for our medical devices together with our distributors
- Preparation, maintenance and evaluations/reviews of technical documentation from a regulatory affairs perspective
- Review and approval of product labels and promotional materials to ensure regulatory compliance
- Implement measures to ensure products and processes meet regulatory requirements
- Advise and support other departments (e.g., R&D, marketing, and quality assurance) on regulatory issues
- Communicate with regulatory agencies and other stakeholders to obtain feedback and guidance on regulatory issues
Your Profile:
- Bachelor's/Master's degree in medical technology, engineering, or a related field
- Several years of experience in regulatory affairs
- Knowledge of international regulatory requirements and processes
- Strong communication and negotiation skills
- Strong organisation and problem-solving skills
- Fluent in English
