Regulatory Affairs Intern
Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA.
At Flen Health, we focus on people with topical inflammatory and infectious diseases. Our vision is to shape a world, where wounds and skin disorders do not stop patients from living the life they love by developing innovative technologies and distributing them across the globe.
At Flen Health, we expect you to show grit, take ownership of your initiatives, to go for it and we guarantee that you will then appreciate the result of your work, whether individually, as a team or companywide as Flen Health. As an intrapreneur, you will enjoy working in a multicultural diverse environment where trust and open communication are key, and where a positive can-do attitude drives sustainable growth. We offer a flexible working ecosystem and enthusiastic colleagues.
We are looking for a Regulatory Affairs Intern for 4 to 6 months based either in Belgium or in Luxembourg to strengthen our Regulatory Affairs team.
As Regulatory Affairs Intern, you support the Regulatory Affairs Team concerning the registration and the maintaining of all Flen Health products in the countries where Flen Health commercializes its goods and services in order to cope with the ISO standards and other regulations.
This position would suit you perfectly if you are eager to learn and driven by a passion for healthcare innovation.
Your responsibilities:
As a Regulatory Affairs Intern, your key missions will include:
Participate in regulatory activities such as the registration and maintenance of medical devices:
- Assist in preparation and submission of regulatory documentation to support medical device registration and compliance in various markets
- Help to maintain existing registrations in accordance with local and international regulatory requirements
Support the regulatory team in global development activities related to the MDD-MDR transition:
- Collaborate with the team to ensure a smooth transition of medical devices from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) framework
Contribute to the update of medical device regulatory dossiers (MDD-MDR):
- Review, edit, and update technical documentation to align with MDR requirements
- Ensure all necessary details are accurately reflected in regulatory submissions
Assess changes to products and processes and update regulatory activity procedures:
- Evaluate proposed changes to devices or manufacturing processes to determine regulatory implications
- Revise and maintain internal regulatory procedures to ensure compliance with the latest regulations
Handle internal and external requests for regulatory documentation:
- Respond to requests from internal teams, customers, or regulatory authorities for technical or compliance-related information
- Prepare and organize required documentation efficiently and accurately
Participate in regulatory and standards monitoring:
- Track updates to relevant regulations, standards, and guidance documents
- Inform the team of changes and assist in implementing any required updates
Review and validate marketing and promotional documents:
- Ensure that marketing and promotional materials comply with regulatory guidelines and standards
- Provide feedback and recommendations to ensure clear, accurate, and compliant communication
Support various projects such as preparing for third-party audits or international product registrations:
- Assist with the preparation of documentation and processes for audits by notified bodies or regulatory authorities
- Support the registration of products in international markets by gathering and submitting required documentation.
What You’ll Gain:
- Hands-on experience in regulatory affairs within the medical device industry
- A deeper understanding of ISO 13485, MDR and global compliance standards
- Exposure to cross-functional teams in a multicultural environment
- Professional development in regulatory documentation, technical dossier management, and compliance strategies.
Your qualifications & experience:
- You are currently pursuing a Master’s degree in Engineering, Pharmacy or related field, preferably with a focus on Regulatory Affairs
- You can demonstrate basic knowledge in regulatory affairs and medical devices which allow you to understand the regulatory contexts and technical documentation
- You are motivated to take care of assigned tasks and projects with commitment
- You demonstrate good organization skills and are detail-oriented
- You show a strong team spirit and a taste to work with cross-functional teams
- You are eager to learn and keen to take responsibilities
- Your are proficient in Microsoft Office tools
- You are fluent in English, oral and written. Other languages such as Dutch, German or French are an asset.
What we offer:
- Excellent working conditions
- An innovative and inspiring work environment
- Opportunities to learn and develop your skills within a professional team.