Lead Regulatory Affairs Engineer

Are you a current Elekta employeePlease click here to apply through our internal career site Find Jobs - Elekta .Want to join a team with a mission to improve and save livesWe continually look for motivated and skilled individuals who are interested in supporting our customers healthcare professionals who use our products to help patients and their communities.We currently have the following opportunity available - please contact us for more detailsWe dont just build technology. We build hope for everyone dealing with cancer.What youll do at ElektaAs a Lead Regulatory Affairs (RA) Engineer you will coordinate and manage the delivery of regulatory expertise across projects ensuring alignment with Elektas release and domain strategies. You will play a vital role in supporting regulatory submissions and maintaining compliance while also working ahead of project teams to ensure smooth execution and adherence to regulations. Your scope will include leading RA planning and backlog management supporting PI planning and acting as a deputy for the Director of RA when needed.Key responsibilities include :Act as functional interface to the Project Management Office for regulatory needsManage the RA task backlog and ensure resource planning in coordination with the Director of RAProvide regulatory expertise across domain and release projectsDrive execution of RA management decisionsProactively identify and lead continuous improvement opportunitiesSupport the development of departmental strategies and trainingRepresent RA in roadmap discussions and cross-functional planningParticipate in PI planning and raise regulatory actions for planning cyclesEnsure adherence to global regulatory and safety requirementsSupport worldwide regulatory submissions including FDA Health Canada Japan and ChinaDeputize for RA Director and substitute for RA engineers when neededThe right stuffStrong leadership and conflict resolution abilitiesAbility to influence and build strong cross-functional relationshipsEffective communication skills at all organizational levelsCollaborative mindset with the ability to mentor and drive problem-solvingStructured detail-oriented and able to work independentlyPositive attitude toward change and continuous improvementWhat you bringAt least 7 years of experience in Regulatory Affairs within the medical device industryProven project or program management experience preferably in Agile environmentsExperience with radiotherapy or radiosurgery is a plusFamiliarity with international regulatory standards and submissionsBSc or MSc in Engineering or equivalentExperience with quality assurance compliance and auditsProficient in Microsoft Office and common IT toolsExcellent English language skills (written and verbal)Experience working in a multicultural environmentWhat youll getIn this role you will work for a higher purpose : hope for everyone dealing with cancer and for everyone - regardless of where in the world they live - to have access to the best cancer addition to this Elekta offers a range of benefits.Hiring processWe are looking forward to hearing from you Apply by submitting your application and résumé in English via the Apply button. Please note that we do not accept applications by e-mail.Your Elekta contactFor questions please contact the Global Talent Acquisition Partner responsible Gustaf Ericson at . We do not accept applications through e-mail.We are an equal opportunity employerWe are an equal opportunity employer. We evaluate qualified applicants without regard to age race colour religion sex sexual orientation gender identity genetic information national origin disability veteran status or any other protected characteristic.About ElektaAs a leader in precision radiation therapy Elekta is committed to ensuring every patient has access to the best cancer care possible. Elekta is a proud innovator and supplier of equipment and software used to improve prolong and save the lives of people with cancer and brain disorders.More than 6000 hospitals worldwide rely on Elekta technology. We openly collaborate with customers to advance sustainable outcome-driven and cost-efficient solutions to meet evolving patient needs improve lives and bring hope to everyone dealing with cancer. To us its personal and our global team of 4700 employees combine passion science and imagination to profoundly change cancer care. We dont just build technology we build hope.Elekta is headquartered in Stockholm Sweden with presence in more than 120 countries and listed on Nasdaq Stockholm. For more information visit or follow @Elekta on Twitter and on LinkedIn.Key SkillsProofreadingAdobe AcrobatFDA RegulationsManufacturing & ControlsBiotechnologyClinical TrialsResearch & DevelopmentGLPcGMPProduct DevelopmentChemistryWriting SkillsEmployment Type: Full-TimeExperience: yearsVacancy: 1 #J-18808-Ljbffr