Senior Regulatory Specialist

About this role

Building anAI‑first organisationis central to Clinisys’ purpose and the impact we deliver. As a global provider of intelligent diagnostic informatics solutions, we build AI‑enabled, cloud‑based platforms to enhance diagnostic workflows across healthcare, life sciences, and public health. By applying intelligent technology thoughtfully and responsibly, we help laboratories and testing environments operate more effectively, generate meaningful insights at scale, and ultimately support healthier and safer communities. Operating across more than 30 countries, Clinisys expects all colleagues—regardless of role or function — to work confidently with AI‑enabled tools, apply digital and analytical thinking, and continuously adapt as technologies evolve, must drive an AI first sense of purpose and urgency.
Clinisys has built an unrivalled reputation for deploying complex diagnostic networks and academic centres – and is the only provider to repetitively deliver to all disciplines end-to-end – at scale. Fostering healthier communities.
Job Overview
AsaSeniorRegulatoryAffairsSpecialist,youwillsupportClinisys'globalregulatoryactivities,ensuringcomplianceacrossmultipleinternationalmarketsandregulatoryframeworks.
WorkingcloselywithQuality,ClinicalSafety,ProductManagement,R&D,OperationsandLegalteams,you'llprovideregulatoryexpertisethroughouttheproductlifecycle,fromproductdevelopmentandmarketaccessthroughtopost-marketcompliance.You'llplayakeyroleinregulatorysubmissions,productregistrations,changeassessmentsandregulatorystrategy,helpingClinisysnavigateanevolvingglobalregulatorylandscape.
Responsibilities

• Leadregulatoryactivitiesforassignedproductportfolios,developingstrategiesthatsupportglobalmarketaccess,productlifecyclemanagementandbusinessobjectives.

• ActastheRegulatoryAffairssubjectmatterexpert,providingguidancethroughouttheproductlifecycle,includingproductdevelopment,softwarereleases,designchanges,commercialisation,post-marketactivitiesandmarketexpansion.

• Leadthepreparation,reviewandsubmissionofregulatoryfilings,registrations,certificationsandmarketaccessactivitiesacrossglobaljurisdictions.

• Assesstheregulatoryimpactofproductchanges,emergingregulationsandindustrystandards,translatingregulatoryrequirementsintopracticalbusinessrecommendations.

• Identifyandmitigateregulatorycompliancerisks,supportingrisk-baseddecision-makingandensuringongoingcompliancewithglobalregulatoryrequirements.

• Leadregulatoryworkstreamswithincross-functionalprojects,influencingstakeholdersacrossProduct,R&D,Quality,ClinicalSafety,CommercialandOperationsteams.

• RepresentRegulatoryAffairsduringaudits,inspections,customerduediligenceactivitiesandinteractionswithregulatoryauthorities,notifiedbodiesandcertificationbodies.

• Supportthecontinuousimprovementofregulatoryprocesses,governanceandcomplianceframeworks.

Essential Experience

• Bachelor'sdegreeinascientific,engineering,healthcare,regulatoryaffairsorrelateddiscipline.

• 5+years'RegulatoryAffairsexperiencewithinaregulatedindustry,ideallymedicaldevices,diagnostics,healthcaresoftware,digitalhealthorlifesciences.

• Experiencepreparing,supportingormanagingregulatorysubmissions,registrations,certificationsandmarketaccessactivities.

• Experiencesupportingregulatorycompliancethroughouttheproductlifecycle.

• Strongknowledgeofglobalregulatoryrequirements,includingFDA,EUMDR,IVDR,UKMedicalDeviceRegulationsandassociatedstandardssuchasISO13485,ISO14971andIEC62304.

• Experiencesupportingaudits,inspectionsandinteractionswithregulatoryorcertificationbodies.

• Excellentcommunication,stakeholdermanagementandorganisationalskills.

Desirable Experience

• RegulatoryAffairsCertification(RAC)orequivalent.

• ExperiencewithSoftwareasaMedicalDevice(SaMD),healthcaresoftware,laboratorysystems,diagnosticsordigitalhealthtechnologies.

• Experiencesupportingproductsacrossmultipleinternationalmarkets.

• Previousexperienceinatechnical,scientific,qualityoroperationalrolebeforemovingintoRegulatoryAffairs.

• ExperienceusingAI-enabledtoolstosupportregulatoryresearch,monitoringandcomplianceactivities.

This role requires a working knowledge of Artificial Intelligence (AI) technologies and the ability to leverage them to improve processes and outcomes. A core understanding of AI concepts is required and must be able to demonstrate the use of AI tools in a professional setting.
Onboarding
As part of our onboarding process, all new employees will be required to attend / travel to the office on their first day of employment. This requirement is essential for onboarding activities, including the identity verification, completion of necessary documentation, receiving your IT equipment, introductions to key team members, and orientation to Clinisys policies and procedures.
Originally posted on Himalayas