Senior Regulatory Specialist
Free to start · No card · 5 credits the moment you sign up
Job description
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
Prepare your application
Use the description above to assess your fit for Clinisys. This checklist is guidance from Resumize, rather than additional requirements from the employer. Imported listings can be shortened or change after collection, so confirm the complete description and current availability before sending an application.
Match requirements to evidence
Identify the responsibilities and skills the employer explicitly names. For each important requirement, choose one example from your work, education, training, or projects. Explain what you did, how you did it, and what changed as a result. Include a measurable outcome when you can support it. If you lack a requirement, describe related experience accurately instead of adding an unfamiliar skill to your resume.
Put the most relevant examples near the top of your resume. Keep job titles, dates, qualifications, and contact details consistent across your application materials. Use the employer’s terminology when it describes your experience accurately; a copied list of keywords does not explain your contribution. A short, specific bullet is easier to review than a paragraph that mixes several unrelated duties.
Check the working arrangement
Confirm the location, schedule, employment type, and any eligibility requirements on the employer’s site. A remote label does not establish worldwide eligibility or flexible hours. If compensation, benefits, equipment, travel, or contract duration are missing from this listing, write down your questions for the recruiter. Do not assume details from another opening at the same company apply to this role.
Review before submitting
Follow the employer’s requested file format and application instructions. Open your exported resume and check that its text is selectable, its sections read in order, and its links work. Proofread names, dates, and contact information. Share confidential work samples only when you have permission, and use an anonymized example when necessary.
Submit through a trusted employer or recruiting destination. If the original listing has disappeared, search the employer’s careers page for the title rather than assuming the vacancy remains open. Save the application date, job reference, and the version of your resume you sent. Those details help you prepare for a later conversation and avoid submitting conflicting information through several job boards.
Review your resume for writing and readability feedback, or browse other openings if this opportunity is unavailable.