SUSONITY
Associate Director in Data Science, Digital Health Analytics and Innovation(m/w/x)
Full-timeOn-siteSenior
Darmstadt
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SUSUSONITY
Director, Regulatory Lead - Medical Device - Bioelectronics(m/w/x)
Darmstadt
Full-time, Part-timeOn-siteSenior
Nejo AI Summary
Global regulatory strategy for class III implantable neurostimulation devices. Health authority spokesperson and documentation authoring required. Full-time employment.
Requirements
- MSc or higher in Life Science or related discipline (PhD preferred)
- Proven track record in IDE/510(k)/PMA filings, eSTAR processes, and quality systems application
- Strong understanding of clinical development, trial design, and regulatory frameworks
- Demonstrated ability to build and execute global regulatory strategy (EU and US submissions)
- Proven capability to engage health authorities and serve as spokesperson
- Solid knowledge of EU/US regulatory frameworks for medical devices and combination products
- Excellent collaboration and communication within multidisciplinary teams
- Ability to lead and prioritize in global, matrixed environment and work autonomously
- Mandatory fluency in English
Tasks
- Drive global regulatory strategy for class III implantable neurostimulation devices
- Prepare and lead health authority interactions with FDA, Notified Bodies, and EMA
- Represent Global Regulatory Affairs in Governance meetings
- Author and review device documentation for health authority submissions
- Coach colleagues in Regulatory Affairs and related functions
- Participate in QMS ISO 13485 and 21 CFR 820 audits
- Identify opportunities to build trust and scientific credibility
- Work effectively in a matrixed organization
- Demonstrate fluency in English and lead collaboratively
Work Experience
- 10 - 15 years
Education
- Master's degree
Languages
- English – Native
Tools & Technologies
- IDE
- 510(k)
- PMA
- eSTAR
- ISO 13485
- software validation
- human factors
- design verification
- design validation
- ICH
- GCP
- ISO 14155
- EU-MDR
- MPDG
- MDCG
- MDSAP
Benefits
Job Security
- Full-time employment
Flexible Working
- Part-time employment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SUSONITY 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.
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SUSUSONITY
Director, Regulatory Lead - Medical Device - Bioelectronics(m/w/x)
Darmstadt
Full-time, Part-timeOn-siteSenior
Nejo AI Summary
Global regulatory strategy for class III implantable neurostimulation devices. Health authority spokesperson and documentation authoring required. Full-time employment.
Requirements
- MSc or higher in Life Science or related discipline (PhD preferred)
- Proven track record in IDE/510(k)/PMA filings, eSTAR processes, and quality systems application
- Strong understanding of clinical development, trial design, and regulatory frameworks
- Demonstrated ability to build and execute global regulatory strategy (EU and US submissions)
- Proven capability to engage health authorities and serve as spokesperson
- Solid knowledge of EU/US regulatory frameworks for medical devices and combination products
- Excellent collaboration and communication within multidisciplinary teams
- Ability to lead and prioritize in global, matrixed environment and work autonomously
- Mandatory fluency in English
Tasks
- Drive global regulatory strategy for class III implantable neurostimulation devices
- Prepare and lead health authority interactions with FDA, Notified Bodies, and EMA
- Represent Global Regulatory Affairs in Governance meetings
- Author and review device documentation for health authority submissions
- Coach colleagues in Regulatory Affairs and related functions
- Participate in QMS ISO 13485 and 21 CFR 820 audits
- Identify opportunities to build trust and scientific credibility
- Work effectively in a matrixed organization
- Demonstrate fluency in English and lead collaboratively
Work Experience
- 10 - 15 years
Education
- Master's degree
Languages
- English – Native
Tools & Technologies
- IDE
- 510(k)
- PMA
- eSTAR
- ISO 13485
- software validation
- human factors
- design verification
- design validation
- ICH
- GCP
- ISO 14155
- EU-MDR
- MPDG
- MDCG
- MDSAP
Benefits
Job Security
- Full-time employment
Flexible Working
- Part-time employment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SUSONITY 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?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
SUSONITY
Industry
Healthcare
Description
Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.
Not a perfect match?
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