Regulatory Affairs Professional
This role is responsible for ensuring the organization meets its legal obligations regarding product authorization, CE marking, and related information. The ideal candidate will have a degree in Regulatory, Public Health, Politics, Business and Economics, Life or Clinical sciences, with at least 2 years of experience in the Medical device / Pharma / Life science / Food industry, and related Regulations and Guidelines.
Main Responsibilities:
- Manage and improve products authorization process in targeted non-EU countries by preparing and submitting technical documentation dossier collaborating with involved stakeholders.
- Ensure that all CE marking and authorization documents are complete (up to date) and supporting other RA associates within the team for the product lifecycle management, including post market activities (PMS, PSUR, SSCP, Vigilance, etc).
- Responsible for product-related information that is legally required to support the activities of the organization.
Requirements:
- Methodical and resilient when it comes to managing repetitive administrative work.
- Process and policy oriented, analytical thinking, able to manage policies, procedures and databases.
- Customer focus, self-determination, autonomous and self-supporting.
- High flexibility and resilience in adapting to a fast-pacing regulatory environment.
- Excellent command of both written and spoken English (any other language will be considered).
- Good verbal and written communication skills, ability to interface with different cultures and external bodies.
We Offer:
- Challenging job in a growing international company.
- Multicultural environment.
- Flexible hours.
- Competitive salary including benefits (meal vouchers, hospitalization and group insurance).