RA Manager - Regulatory Devices (d/f/m), Kundl, Austria

Job Description Summary

The Regulatory Affairs Device Manager (m/f/d) role is a global role within Sandoz Regulatory Affairs. In this role you will be responsible for delivering and maintaining global compliance and regulatory approval of medical devices and combination products which range from simple drug administration tools to complex needle-based injection systems and on-body devices. Job Description

The Regulatory Affairs Device Manager role is a global role within Sandoz Regulatory Affairs. In this role you will be responsible for delivering and maintaining global compliance and regulatory approval of medical devices and combination products which range from simple drug administration tools to complex needle-based injection systems and on-body devices. The ideal candidate for this role brings advanced device regulatory experience (5+ years), can independently drive regulatory stakeholder interactions (e.g. Notified Body, EMA, FDA), and can define strategies and lead others to successfully plan coordinate, develop, and deliver high quality regulatory and technical documents for successful registration of both, stand-alone medical devices and drug-device combination products. This position can be based in Kundl (AT), Holzkirchen (DE) or Ljubljana (SLO). Your Key Responsibilities:

Core member of medical device and combination product development teams, providing high quality regulatory input to ensure that the developed product meets global Health Authority expectations Primary point of contact for Notified Body and global Health Authorities for stand-alone medical device registrations and leadership of MDR Article 117 Notified Body Opinion interactions Deliver high quality regulatory documents to support global Health Authority submissions for combination products and stand-alone medical devices. Supports audit readiness activities and inspections for medical devices and combination products including obtainment and maintenance of certification for stand-alone medical devices Write and maintain high-quality regulatory documents and responses for Health Authorities and Notified Bodies according to established guidelines, processes, IT systems and SOPs, to ensure technical congruency and regulatory compliance while meeting agreed timelines and submission requirements Regulatory lead for the development / manufacture of medical devices and combination products, including management of relevant registration, certification, and audit requirements. Operational owner of medical device and combination product related deliverables and timelines Regulatory device lead for post approval phase, supporting global registrations, responsible for evaluation of changes, definition of implementation strategies and submission of variations Strategic oversight of medical device and combination product regulatory activities - ability to lead others to ensure successful identification of device deliverables, completion of deliverables in-line with development milestones and successful integration into dossiers and successful response to health authority deficiency letters or requests for information What you'll bring to the role:

Essential Requirements:

Advanced University degree or equivalent education/degree in engineering or life science/healthcare is required (minimum requirement Masters degree or equivalent) 5+ year industry experience working in medical device/combination product development or registration with a solid grasp of relevant regulations and standards including MDR 2017/745, 21 CFR 820 / 21 CFR 4, ISO 13485 and ISO 11608 Proven track record of supporting development of medical devices or combination products starting from design planning through to design transfer Experience in the generation of the technical file for stand-alone device submission or experience in the generation of Notified Body Opinions or relevant CTD modules for combination products including module 3 sections P2.4, P3.5 and P7 Experience in the generation or review of Clinical Evaluation Protocols and Reports for medical device submissions Fluent in English (oral and written) - with excellent verbal and written communication skills Ability to lead others to achieve results in a complex highly matrixed environment Desirable Requirements :

Experience leading teams and topics and within area of expertise in a matrix environment High change agility - ability to adapt quickly & effectively in a dynamic environment. Proactively / independently engages with internal and external stakeholders. Can clearly communicate complex topics to other experts / stakeholders You´ll receive:

Attractive salary with incentive program Modern company pension scheme Flexible working hours / home-office depending on the position 14 weeks of paid parental leave Additional days off (bridge-days) Subsidized meals in our canteen Sustainable mobility in form of company transportation an

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