Design Quality Lead DHT and SaMD

This is what you will do:

Theprimary purpose of this position istobuildinternalQMSoversightforAI DHT orAISaMDdevelopmentwithbusinesspartneringAIDHT /AISaMDcompanies. Thebusinesspartner(BP)shall develop thetechnologiesand shallexecute processes in line with their own QMS.TheBPshall also complete the regulatory submissions for theproductunless Alexiondecides to perform this role.TheDHTQshall ensure key quality criteria are in place in the Alexion QMS so that development work can start andoversee theBPdesign control activity to ensurekey quality milestones are achievedfor EU andUS markets.

TheDHTQis the quality liaison betweenDiagnostics Strategy & Development group (Product Development),MedicalDeviceQualityandRegulatory Affairsto ensureinternal and partnercompliance withQuality Standards, Regulations and Design control activitiesfor the clinical and commercial development ofAI DHT/ AISaMD products. Therole enables efficient communication for decision making related to qualityandproduct development. 

You willbe responsible for:

• Responsible for creating QMS related SOPs and/or guidance documents for the collaboration withBPto meet requirements of ISO 13485:2016, IVDR,IEC 62304,FDAPart 820 QMSR.Clearlyidentifyroles and responsibilities for Alexion and BPs for device technical documentationgenerationincluding DHF and Device Clinical Performance.

• Support R&D Quality in the supplier qualification process (Operational Due Diligence)during the onboarding ofBPfor clinical development.

• Responsible for ensuring thatBPdevelopment process and regulatory strategy forsuch devicesand systemscomply withall WW regulatory requirements.Quality responsibilities forBPfor which theDHTQshallhave oversight shallbe documentedin aBP qualityoversight plan.

• Identification of anyknown or newgaps to SOPs. Support product developmentcreateQuality Plansor document mitigationsto ensure gaps and risks are addressed appropriately ensuring project deliverables arecompliantlykept on track.

• Liasewith AstraZeneca partners toleverageexisting resources,processesand procedures. Whereappropriateinvolve AstraZeneca partnersto supportprogramdeliverables.

• DeviceBPsshall supply Alexion withmilestone development summary reportsper the quality oversight plan. TheDHTQ shallbe responsible forQuality oversight, participationin thereview and approval of key deliverables including DesignDevelopment,Regulatory submissions,Design Transfer activities including CAPA, Risk Management, Change control, Design Reviews. 

• Responsible for providing input and review of DesignControldeliverablese.g.perISO 13485:2016 Section 7.3Design and Developmentand IEC 62304.

• Assistin quality review of Regulatory submissions and response to queries.

• Supports regulatory inspections and compliance.

• Supports cross functional activity to ensure audit readiness is in place for all aspects of the product lifecycle.

• Other duties as assigned.

You will need to have:

• B.Sc. / B Eng degree in Engineering or Science or equivalent experience in regulated industry.

• Preferable7years+’ cGMP experience within quality in a medical device,SaMDR&D, ideally clinical phases through commercial 

• Understanding ofMedical device development for the full lifecycle starting at the Design Control phases.

• Knowledge of the regulatory and compliance requirements of design control forAI DHT / AI SaMDmedical devices (FDA QSR 21 CFR Part 820 / ISO 13485 and Regulation (EU) 2017/745).

• Demonstrated ability in decision making, problemsolvingand project management.  

• Collaborate, negotiate, influence and lead in a matrix organization 

• Excellent communication and interpersonal skills

• Proven record indemonstratingagility 

We wouldpreferforyou to have:

• Experience in successful development, filing and gaining approval for global regulatory submissions

• Experience indevelopment ofAI DHT / AI SaMDandregulatoryapproval510(K), De Novo or PMA.