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Regulatory Affairs Specialist
As a total solution provider of medical devices and pharmaceutical packaging, our client is continuously committed to improving patient outcomes and quality of life. They are looking today for their RA Specialist Custom Solutions (CS). That person will be responsible for Market Authorization process of Medical Devices and In Vitro Diagnostics within EMEA (and beyond on exceptional basis.)
WHAT YOU'LL DO
- Manage and supervise registration dossiers by coordinating and interacting with internal stakeholders (Branches, legal manufacturers, customers…)
- Liaising registrations between Custom Solution customers and legal manufacturers
- Closely cooperating with sales dept. for regulatory changes that are impacting CS customers
- Coordinate, plan and interact with relevant internal and external stakeholders
- Review of agreements for CS customers
- For the dedicated territories, exhibit a good understanding on the in-countries regulations and guidelines to ensure that all regulatory aspects are closely monitored and fulfilled (or work with local expert in case of complex national requirements).
- Keep track of local registration requirements and timelines.
- Build relationships and network with relevant external stakeholders
- Contributing to internal projects within various department where RA expertise would be required
- Build relationships and network with relevant external stakeholders.
- You’ll perform all tasks in accordance with ISO and JSOX requirements and taking the company’s values into account.
- Provide RA support for registration
WHAT YOU'LL NEED
- A bachelor’s degree and at least 2 years of relevant experience in a medical devices company
- You are knowledgeable about medical regulation
- You enjoy administrative work
- You have an eye for detail and work accurately
- A positive spirit combined with great flexibility
- You enjoy working in a team and perform at your best in a team culture where open communication and collaboration is highly valued.
- Good knowledge of MS Office, especially Excel
- English is a must, every other language is a plus