Regulatory Affairs Manager
The Company
The company is located in Amsterdam and is active in Consumer Health. They have a diverse product portfolio. The company is active in more than 25 countries.
Role Description
We are looking for a full time Quality/Regulatory Affairs Manager for the whole product portfolio who has knowledge in regulations and other standards. You will report directly to the director. The company is a midsize Medical Device company so you will be responsible on a broad aspect. You will collaborate with the Supply Chain department but also with the Sales and R&D department.
Requirements
Your qualifications & experience
The company is located in Amsterdam and is active in Consumer Health. They have a diverse product portfolio. The company is active in more than 25 countries.
Role Description
We are looking for a full time Quality/Regulatory Affairs Manager for the whole product portfolio who has knowledge in regulations and other standards. You will report directly to the director. The company is a midsize Medical Device company so you will be responsible on a broad aspect. You will collaborate with the Supply Chain department but also with the Sales and R&D department.
Requirements
Your qualifications & experience
- You will be responsible for the registrations like MDD, 93/42/EEC, MDR and ISO 13485
- Doing the total registrations and create the technical documentations
- Build up a network in Notified Bodies and other authorities to create a global market access
- guide Audits with the Notified Body and other clients
- Master Degree in Pharmaceuticals or Life Science related
- 8+ years experience in similar role with a preference in Consumer Healthcare
- punctual and solution-oriented mind set
- Strong interest in consumer healthcare products
- Fluent in Dutch and English
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