Our client a global wound care company are recruiting for a Regulatory Specialist to join their successful team based in at their sites in either Belgium or Luxembourg.
Your qualifications & experience:
- You support the Regulatory Affairs’ department in preparing product technical dossiers and other regulatory documents for registration submissions in and outside EU
- You support the Regulatory Affairs’ department in keeping product technical dossiers and other regulatory documents up to date during the lifecycle of the companies products
- You participate in the implementation of the new Medical Device Regulation
- You ensure the regulatory compliance of communication activities and materials (brochure, presentation, packaging material etc.) regarding the companies products, in close collaboration with marketing and sales
- You keep abreast of international legislation, guidelines and customer practices by keeping in contact with official institutions
- You identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated
- You work in close collaboration with and report to the Manager Regulatory Affairs
Your profile:
- Master’s degree in Pharmaceutical Science or Master in Science or equivalent based on relevant experience.
- At least two years of professional experience in Regulatory Affairs for medical devices
- Experience in international regulatory affairs is required; knowledge of regulatory affairs related to FDA and other non-EU regulations also
- Project management knowledge is an asset
- Familiar with MS Office and database applications
- English is mandatory; Strong communication skills both written and verbal
- Excellent planning and organisational skills
- Quality minded
- Strong interpersonal skills
- Problem solving ability
- Strong analytical ability
What we offer:
- Excellent working conditions
- An innovative and inspiring work environment
- Independent project work & responsibilities within a professional team
- Career prospect
- Learning and development opportunities
- Competitive remuneration according to experience