Regulatory & Vigilance Assistant
We are a rapidly growing and innovative health care company based in Belgium, with a dynamic team of entrepreneurial minded people. Creating value through scientific progress and consumer insights is in our DNA. Our products are marketed internationally under our own brands or under the brand name of our partners.
As a Regulatory Assistant, within Regulatory & Vigilance department, you’ll be responsible for providing administrative and technical support related to the daily activities of your manager as well as experts, specialists and officers.
As our Regulatory & vigilance assistant, you’ll work with the different regulations that are applicable under the supervision of the Vigilance Manager
- Input incidents in MasterControl
- Prepare and follow up notifications to Notified Body and/or Health Authority
- Follow-up with reporter
- Three-monthly reconciliation on request of customers
- Literature report processing
- PMS reports – support in preparation
- Support with legalization and notarization of legal documents (prepare, send to notary online portal of Diplobel)
- Prepare and keep up to date Doc (declaration of conformity) in MasterControl
- Request FSC from Federal Agency of Medicinal Products and Medical Devices
- Prepare invoices of regulatory department for processing by finance
- Regulatory check of customers artwork
You possess a degree and an additional interest in administrative tasks and experience in administrative support
Possessing knowledge and experience concerning medical/pharmaceutical sector, will be regarded as an additional advantage.
You are fluent in English. This is a must and related to both the written and verbal skills.
You are proficient in Microsoft Office and you are open to learn to work with new software programs. In addition, you are accurate, organized and a team player.
You are a problem solver with excellent attention to detail
You have excellent time management & prioritization skills
We offer a full-time employment contract, a fantastic opportunity to work in a top performing company. A work environment in which every associate is treated with respect, where sincerity is key and where everyone always strives to find the most optimal solution.
Place of employment : Merelbeke