Urgently looking for a Regulatory Affairs Specialist for a leading biotech company with the ability to analyze, interpret and synthesize regulation and guideline. Also who will identify regulatory issues, risks and priorities, and manage them.
- Label and Instruction for Use – review and approval, and the management thereof.
- Update of RA database.
- Handle all necessary activities for the release of SKU (codes) restrictions.
- Local Management of the MV Project and related communication to all stakeholders.
- Ensure regulatory compliance of Medical Devices (MD) for their access to the market of Belgium, Netherlands and Luxembourg.
- Identify Regulatory Issues & strategies concerning MD, in the scope of the Project, report them to the relevant RA Leaders (at global and local level), investigate and suggest solutions to resolve them.
- Support for One MD Organizations in Netherlands and Belgium related to the Project.
- Provide regulatory support to ensure consistent collaboration with franchises and EMEA/ Regulatory Affairs, and act as the main contact person for any natters related to the Project impact issues.
- Collaborate with local Commercial, Marketing, Tendering, Finance & Supply Chain teams, to ensure flawless completion of the Project and related activities, and accurate and timely reply to stakeholder requests.
Language requirement: Excellent in English and Dutch (write, read and speak)
Advanced level in Excel (mandatory & non-negotiable)
Analytical, self-motivated, energetic and self-disciplined person
Good communication skills
Attention to detail
Able to work in a high-paced environment
Other features of the job:
Knowledge of EU Medical Device requirements will be beneficial
Previous experience in Medical Devices or Pharma industry will be beneficial
- Essential knowledge and skills:
- Education Level: Junior scientist (Pharmacist, Engineer, Biologist, Chemist, etc.)
- Ability to build partnerships internally and externally
- Advanced level in Excel (mandatory & non-negotiable)
- Ability to analyze, interpret and synthesize regulation and guidelines
- Ability to identify regulatory issues, risks and priorities, and manage them
- Consistent skills to work in parallel environments (business and regulation), to provide feedback and background of regulation update and its impact on RA strategy.
- Rigorous and well organized
- Capability of self-awareness and adaptability
- June 15
- 6 months
If you’re interested in the above description, please apply with your CV. For further information, please contact Selin Ozbeden at +31 (0)20 20 44 502 or by email at email@example.com