Regulatory Affairs Officer

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 dynamic can-do attitude drives sustainable growth.

We offer
a positive and engaging workplace, enthusiastic colleagues, and an attractive remuneration package. We are looking for a Regulatory Affairs Officer for an immediate start to reinforce our Regulatory Affairs department. This is a permanent full-time position based in our office in Belgium, Kontich or in Luxembourg, Esch-sur-Alzette. The Regulatory Affairs Officer provides operational support for global regulatory activities, ensuring registrations, regulatory documentation, and product information are maintained accurately and on time across markets. This position will suit you perfectly if you have a taste for challenges and the desire to make things happen Your

responsibilities:
Regulatory Operations
• Support preparation and coordination of regulatory submissions
• Manage registrations, renewals and routine regulatory maintenance activities
• Maintain and support regulatory databases (such as EUDAMED etc.), trackers, certificates and submission records
• Follow up on regulatory actions, commitments and deadlines
• Coordinate collection and preparation of documents required for submissions and registrations
• Support interactions with affiliates, distributors and other local regulatory contacts
• Ensure the regulatory compliance of communication activities and materials (brochure, presentation, packaging material etc.) regarding Flen Health’s products, in close collaboration with medical, marketing and sales
• Execute and sign for the administrative batch release Technical Documentation & Product Maintenance
• Support updates and maintenance of technical documentation
• Assist with document collection, completeness checks and dossier preparation
• Bring support with maintenance (including changes) of product, labelling, translations and regulatory information
• Participate to implementation and documentation of regulatory changes
• Help ensure consistency of regulatory information (regulatory intelligence) across dossiers, registrations and markets Global & Regional Regulatory Support
• Provide operational support for registrations and maintenance activities outside the EU
• Support APAC, LATAM, MEA and other markets depending on team priorities
• Coordinate documentation requests from affiliates, distributors and local partners
• Contribute to future geographical expansion where required
• Registration in Salesforce and in the quality management system of post market surveillance information (PMS) concerning Flen Health's products and services. In order to be able to improve them and increase client satisfaction in the end, in close collaboration with the regulatory team. Extraction of the collected PMS data and help in preparation of PMS reports Regulatory Team Support & Continuous Improvement
• Contribute to efficient Regulatory Affairs processes, templates and working methods
• Maintain accurate regulatory records and documentation
• Support regulatory intelligence and impact-assessment activities where appropriate
• Participate in cross-functional activities requiring operational RA support
• Develop regulatory knowledge and progressively assume greater responsibility Your qualifications &

experience:
• Bachelor's or master’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or a related field
• 1 to 3 years of relevant professional experience in Regulatory Affairs, preferably within the medical device sector and/or related field
• Familiarity with Quality Management System Medical Devices ISO13485:2016 and Medical Device Regulation EU MDR 2017/745
• Knowledge of Medical Device Technical Documentation, Vigilance, and Post-Market Surveillance requirements, with an understanding of their role in ensuring ongoing regulatory compliance throughout the product lifecycle
• Initial experience supporting regulatory submissions and conformity assessment activities with Notified Bodies
• Experience with international registrations (such as, UK, TFDA, MedDO, CMDR, ANVISA, TGA), and / or other global markets is a plus
• Strong organizational, administrative as well as problem-solving skills
• At ease with cross-functional teamwork
• Proactive and detail-oriented working style
• Ability to manage multiple actions, documents and deadlines
• Interest in developing a career within Regulatory Affairs
• Good written and verbal communication skills in English

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