Senior regulatory affairs specialist

Senior Regulatory Affairs Specialist

Antwerp | Hybri

d
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 experience d Senior Regulatory Affairs Speciali st to help drive global regulatory strategy and support product approvals across international market

s.
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

es.
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)Min imum 5 years’ experience in Regulatory Af
• fairsBackgroun d in IVD and/or medical de
• vicesStrong understandin g 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

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