RA Manager – Regulatory Devices

Sandoz

Regulatory Affairs Device Manager in Sandoz overseeing global compliance of medical devices and combination products. Responsible for regulatory approvals, stakeholder interactions, and team collaboration.

Posted 7/23/2026full-timeKundl • 🇦🇹 AustriaMid-LevelSenior💰 €66,917 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs for medical devices and combination products, ensuring compliance with global Health Authority standards and leading successful submissions. Proven ability to manage complex regulatory processes, including Notified Body interactions and audit readiness.

Highest-signal resume keywords

Regulatory Affairs ExpertiseMDR 2017/745 ComplianceISO 13485 KnowledgeTechnical File GenerationClinical Evaluation Protocols

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document WritingMedical Device RegistrationCombination Product DevelopmentAudit ReadinessSubmission Requirements ManagementHealth Authority InteractionDesign Transfer SupportTechnical File GenerationRegulatory ComplianceChange Evaluation

Soft Skills

LeadershipCommunication SkillsCollaborationProblem-SolvingMatrix Management

Certifications & Qualifications

Advanced University DegreeMasters Degree in Engineering or Life Science

Industry Keywords

Medical Device DevelopmentCombination ProductsNotified Body21 CFR 82021 CFR 4ISO 11608Health Authority SubmissionsRegulatory InputDeficiency LettersSubmission Variations

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

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 and shift buses
Company Kindergarden and summer camps for children
Wellbeing & mental health offers
Learning and development options for your personal and professional growth
Worldwide career opportunities