REGULATORY AFFAIRS EXPERT

Roam Technology is a dynamic, fast growing company specialised in the development, production and distribution of a range of sustainable biosecurity- and hygiene products. Our products are produced in Genk under the highest quality standards and distributed worldwide through a network of local distributors and our own branches. The company is growing rapidly and is active in various sectors including agriculture, intensive livestock farming, the food industry, (drinking) water treatment, the health sector, etc. To support our further growth, we are looking for a Regulatory Affairs Expert who can strengthen our Regulatory Affairs & QSHE team.

Location: Genk

Responsibilities

  • You will be able to support in the development of regulatory strategies for market access of biocides, fertilisers and medical devices together with the RA Manager and Product Management Team.
  • Preparation of authorisation dossiers for biocides/fertilisers/medical devices according to applicable regulations/legislation. This includes:
    • Checking local/national procedure(s);
    • Preparing labels and safety data sheets;
    • Filling in application forms;
    • Compiling and analysing data from various sources, including study reports, laboratories, literature search, …
  • You will need to create and periodically update safety data sheets (in Chemeter)
  • Submitting legal declarations for biocides/medical devices (e.g. FOD, FAGG, …)
  • Requesting certificates of free sale of biocides/medical devices.
  • Ensure compliance of marketing materials (advertisement, brochure,…) with national and international regulations and provide regulatory input for commercial labels.
  • Coordinate and answer regulatory questions from the sales department.
  • Stay updated with the latest regulatory developments and proactively communicate changes to the organisation.
  • Specifically to support the quality team you will help preparing and updating quality management system documentation according to the medical device regulation and EN ISO 13485:2016.

Profile

  • Bachelor’s Degree in Sciences/Chemistry or equivalent through experience.
  • Proven expertise in international regulations of biocides.
  • Experience with Medical Devices Regulation is a plus.
  • Accurate and a real problem-solver.
  • Ability to work effectively in a team.
  • Proactive and motivated to go the extra mile.
  • Excellent critical thinking skills.
  • Detail-oriented with excellent organisational and analytical skills.
  • Honest, transparent and high ethical standards
  • Fluency in Dutch and English, with excellent written and verbal communication skills.
  • Proficiency in Microsoft Office (Word, PowerPoint, Excel) and organisation wide ERP systems

 

Offer

  • Roam Technology offers you an interesting career opportunity and a competitive salary package, including a wide range of benefits such as a company car, laptop, smartphone, insurances, bike leasing, meal vouchers, etc.
  • You will join an organisation with a genuine family oriented culture.
  • On a daily basis, you will work within a driven and dynamic team with short communication lines.
  • You receive thorough internal guidance and are well supported in your personal growth.
  • You have the possibility to manage your work in a flexible way, in terms of hours and location (Flexible working schedule, multi sites, home office).

 

Have you become enthusiastic about this challenging position with a wide responsibility, would you love to work within a growing, innovative environment and does the profile suit you? We would like to meet you!

Applications preferably by email to hr@roamtechnology.com.

Apply Now