Regulatory Affairs Associate
Functieomschrijving
An international medical technology company based in Machelen is looking for a new Regulatory/compliance assistant. Since titles can be somewhat shrouded in ambiguity, you can read more about your responsibilities down below.
- Provide feedback on compliance regarding rules about different kind of medical devises
- Prepare or Revise regulatory applications to achieve increased efficiency
- Continuous studying or learning about new regulatory guidelines linked to the medical technology sector
- Analyse regulatory documents
- Evaluate medical device regulations in different EU member states
- Ensure that information about new regulations is given to the right people
- Maintain communication with different parts of the company to establish international regulations, such as the US food and drug administration FDA
- Able to provide reports to management or other regulatory agencies
- Assist new product launches by delving into the required laws and regulations.
- Update the EMEA company sharepoint with all documentation linked to rules and regulations.
Profiel
A position within compliance is not for everyone. In order to be successful in this sector we are looking for someone who has the following characteristics.
- Possession of a bachelor's degree in law or compliance
- Willingness to learn about the bylaws and regulations of the Medical Technology sector
- Fluent in English, other European languages are a plus.
Aanbod
If you start as a regulatory/compliance assistant you will receive the following benefits:
- Comfortable salary package with a nice array of benefits
- International work environment
- Able to work from home once a week
- Growth potential
- Reimbursement of travel costs
Praktische informatie
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