Senior regulatory affairs specialist

Senior Regulatory Affairs Specialist

📍 Antwerp | Hybri

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We’re partnering with an innovative molecular diagnostics organisation that is advancing precision medicine through cutting-edge diagnostic technologies. As the team continues to grow, we’re looking for an experienced Senior Regulatory Affairs Specialist to help drive global regulatory strategy and support product approvals across international market

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In this role, you’ll work cross-functionally with R&D, Clinical, Quality and Operations teams to bring diagnostic products from development through registration and post-market activiti

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What you’ll be do

• ing:Develop and execute regulatory strategies to support efficient product approvals across global mar
• ketsLead preparation and submission of regulatory documentation including EU and US fil
• ingsSupport interactions with regulatory authorities and authorised representat
• ivesPartner with R&D and Clinical teams to ensure development activities align with applicable regulatory requirem
• entsReview and contribute to technical documentation, including validation, software and risk management f
• ilesSupport clinical validation approaches and regulatory plan
• ningContribute to post-market activities including vigilance and regulatory repor
• tingMonitor evolving regulatory landscapes and provide regulatory intellig
• enceParticipate in audits and inspections where requ

ired
What we’re looking

• for:Bachelor’s degree in a scientific, engineering or related discipline (or equivalent experi
• ence)Minimum 5 years’ experience in Regulatory Af
• fairsBackground in IVD and/or medical de
• vicesStrong understanding of IVDR and US regulatory require
• mentsExperience supporting or leading regulatory submis
• sionsAbility to review and interpret technical documentation and complex dat
• asetsStrong stakeholder management and cross-functional communication s
• killsFluent English, written and s

poken
Nice to

• have:Companion diagnostics ex
• posurePCR and/or software-related regulatory expe
• rienceRegulatory Affairs Certification
• (RAC)Knowledge of post-market surveillance and global regulatory pa

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If you are interested please apply directly or send an email with your CV to c.ruiz@panda-i