Skip to content
New Job?Nejo!

Your personal AI career agent

Back
NONovartis Pharmaceutical Manufacturing GmbH

Senior Expert Risk Management & Control Strategy(m/w/x)

Schaftenau
from 65,604.54 / year
Full-timeOn-siteSenior
Apply now

Expert risk management for medical devices and combination products, defining and assessing technical, design, and use-related risks. Extensive hands-on experience with ISO 14971 and EU MDR required. Focus on clear, regulator-ready documentation and influencing cross-functional stakeholders.

Requirements

  • Advanced degree in engineering, life sciences, or related technical discipline
  • Extensive hands-on experience in medical device and/or drug–device combination product risk management
  • Strong working knowledge of ISO 14971, EU MDR, FDA device expectations, and Quality-by-Design principles
  • Proven ability to translate complex technical risks into clear, regulator-ready documentation
  • Track record of influencing cross-functional stakeholders without direct authority
  • Structured, analytical mindset with strong judgment and decision-making capability
  • Experience across multiple device platforms (e.g. autoinjectors, inhalers, pumps)
  • Exposure to combination products within pharmaceutical development
  • Experience supporting regulatory submissions, audits, or inspections
  • Ability to act as reference point for best practices and emerging regulatory trends

Tasks

  • Act as senior subject matter expert for device and combination product risk management
  • Define, assess, and challenge technical, design, manufacturing, and use-related risks
  • Develop and strengthen control strategies across development and lifecycle stages
  • Drive consistency and quality of Risk Management Files, Plans, and Reports
  • Provide expert guidance on risk acceptability, residual risk justification, and benefit-risk considerations
  • Support health authority submissions and interactions, including inspection readiness and responses
  • Contribute to methodologies, templates, guidance documents, and training materials
  • Coach and mentor junior experts and project team members
  • Proactively engage stakeholders to pre-align on risk positions and avoid late-stage surprises

Work Experience

  • approx. 4 - 6 years

Education

  • Master's degree

Languages

  • English – Native
  • German – Native

Tools & Technologies

  • ISO 14971
  • EU MDR
  • FDA
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharmaceutical Manufacturing GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

Like this job?

Beta

Your Career Agent finds similar jobs for you every day.

Not a perfect match?

100+ Similar Jobs in SchaftenauView all
  • Novartis Pharmaceutical Manufacturing GmbH

    Senior Expert Human Factors Engineering(m/w/x)

    Full-timeOn-siteSenior
    Schaftenau
    from 65,605.54 / year
  • Novartis Pharmaceutical Manufacturing GmbH

    Senior Expert Science & Technology (Process Analytical Sciences)(m/w/x)

    Full-timeOn-siteManagement
    Schaftenau
    from 65,605.54 / year
  • Novartis Pharmaceutical Manufacturing GmbH

    Expert Human Factors Engineering(m/w/x)

    Full-timeOn-siteNot specified
    Schaftenau
    from 59,781.96 / year
  • Novartis Pharmaceutical Manufacturing GmbH

    Senior Expert DSP Development(m/w/x)

    Full-timeOn-siteSenior
    Schaftenau
    from 59,781.96 / year
  • Novartis Pharmaceutical Manufacturing GmbH

    Quality Manager Pilot Plant(m/w/x)

    Full-timeOn-siteManagement
    Schaftenau
    from 65,605.54 / year
View all 100+ similar jobs
Apply now

Nejo is an AI – results may be incomplete or contain mistakes