Regulatory Specialist

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Arrondissement of BrusselsCapital, Brussels, Belgique EPM Scientific Temps plein

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pRegulatory Affairs Specialist
- Medical Devices /ppIndustry: Medical Devices / Medical Equipment Manufacturing /ppAbout the Role /ppAn established international medical device organisation is seeking a Regulatory Affairs Specialist to support regulatory market access, product lifecycle management, and compliance activities across multiple EMEA markets. /ppWorking within a collaborative Regulatory Affairs, Quality Assurance and Compliance team, you will partner with manufacturers, distributors, commercial teams and regulatory authorities to ensure products remain compliant and available across assigned territories. /ppKey Responsibilities /ppRegulatory Submissions Market Access /pulliCoordinate and manage regulatory registrations across multiple international markets. /liliPrepare and maintain registration dossiers, ensuring submissions meet local regulatory requirements and timelines. /liliLiaise with manufacturers, distributors, commercial teams and regulatory authorities to support registration activities. /liliMaintain regulatory documentation and ensure records remain current and audit ready. /liliSupport ongoing compliance obligations related to medical device and IVD products. /li /ulpProduct Lifecycle Management /pulliAssess and coordinate regulatory activities associated with product changes. /liliReview change notifications and ensure appropriate internal stakeholder approval. /liliMaintain oversight of product change documentation and implementation activities. /liliSupport regulatory review of product claims, labelling and marketing materials. /liliMonitor evolving medical device and IVD regulations. /liliInterpret new regulatory requirements and communicate impacts to key stakeholders. /liliProvide practical regulatory guidance to support business decision-making. /liliBuild relationships with relevant industry and regulatory stakeholders. /liliParticipate in process improvement initiatives across Regulatory Affairs and Quality functions. /liliIdentify regulatory risks and opportunities to strengthen compliance processes. /liliShare regulatory knowledge and support internal training activities. /liliContribute to broader team objectives and cross-functional projects. /li /ulpRequirements /pulliBachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or a related discipline. /liliPrevious Regulatory Affairs experience within the medical device industry. /liliUnderstanding of medical device regulations and international registration processes. /liliExperience supporting product registrations, regulatory submissions and lifecycle management activities. /liliStrong project coordination and organisational skills. /liliAbility to manage multiple priorities in a fast-paced international environment. /liliExcellent stakeholder management and communication skills. /liliFluent English required; additional European languages are beneficial. /liliAnalytical, detail-oriented and proactive approach to problem solving. /liliStrong interest in regulatory compliance and continuous professional development. /li /ul

Regulatory Specialist

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