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Team Lead - Clinical Affairs(m/w/x)
Leading global strategy for medical device clinical evaluation and regulatory compliance. Extensive experience in clinical research or medical device evaluation with international team leadership expected. 30 vacation days, flexible hybrid work.
Anforderungen
- Advanced scientific, medical, or technical degree
- Extensive clinical affairs or research experience
- Background in Class I–III medical devices
- Leadership experience managing international teams
- Experience in Clinical Affairs, Research, or R&D
- Clinical and regulatory background for medical devices
- Knowledge of EU MDR, FDA, and GCP
- Experience in clinical studies and evaluations
- Ability to translate research into marketing
- Stakeholder management and project leadership skills
- Understanding of GDPR and data protection
- Very good English and German skills
Aufgaben
- Define and lead the global Clinical Affairs strategy
- Align clinical goals with product and regulatory objectives
- Lead and develop an international Clinical Affairs team
- Oversee clinical evaluation and scientific marketing communication
- Ensure clinical compliance with EU MDR and FDA requirements
- Build networks with investigators and research partners
- Train authors and evaluators on regulatory compliance
- Translate clinical insights into product innovation
- Convert research evidence into high-impact educational content
- Ensure GDPR compliance in clinical collaborations
- Manage clinical studies to support regulatory approvals
- Represent the company in communications with regulatory authorities
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- EU MDR
- FDA regulations
- Good Clinical Practice
- GDPR
Benefits
Flexibles Arbeiten
- Flexible working hours
- Hybrid work model
Lockere Unternehmenskultur
- Mutually-supportive international team
Sinnstiftende Arbeit
- Meaningful work
Mehr Urlaubstage
- 30 vacation days
- December 24th and 31st off
Firmenfahrrad
- Bike leasing
Parkplatz & Pendelvorteile
- Parking garage
- Safe underground bike storage
Gratis oder Vergünstigte Mahlzeiten
- Subsidized company restaurant
Snacks & Getränke
- In-house cafes
Gesundheits- & Fitnessangebote
- 360m2 company gym
- Fitness program
Team Events & Ausflüge
- Regular after work events
- Team and company events
Weiterbildungsangebote
- Comprehensive training
- Continuing education opportunities
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Team Lead - Clinical Affairs(m/w/x)
Leading global strategy for medical device clinical evaluation and regulatory compliance. Extensive experience in clinical research or medical device evaluation with international team leadership expected. 30 vacation days, flexible hybrid work.
Anforderungen
- Advanced scientific, medical, or technical degree
- Extensive clinical affairs or research experience
- Background in Class I–III medical devices
- Leadership experience managing international teams
- Experience in Clinical Affairs, Research, or R&D
- Clinical and regulatory background for medical devices
- Knowledge of EU MDR, FDA, and GCP
- Experience in clinical studies and evaluations
- Ability to translate research into marketing
- Stakeholder management and project leadership skills
- Understanding of GDPR and data protection
- Very good English and German skills
Aufgaben
- Define and lead the global Clinical Affairs strategy
- Align clinical goals with product and regulatory objectives
- Lead and develop an international Clinical Affairs team
- Oversee clinical evaluation and scientific marketing communication
- Ensure clinical compliance with EU MDR and FDA requirements
- Build networks with investigators and research partners
- Train authors and evaluators on regulatory compliance
- Translate clinical insights into product innovation
- Convert research evidence into high-impact educational content
- Ensure GDPR compliance in clinical collaborations
- Manage clinical studies to support regulatory approvals
- Represent the company in communications with regulatory authorities
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- EU MDR
- FDA regulations
- Good Clinical Practice
- GDPR
Benefits
Flexibles Arbeiten
- Flexible working hours
- Hybrid work model
Lockere Unternehmenskultur
- Mutually-supportive international team
Sinnstiftende Arbeit
- Meaningful work
Mehr Urlaubstage
- 30 vacation days
- December 24th and 31st off
Firmenfahrrad
- Bike leasing
Parkplatz & Pendelvorteile
- Parking garage
- Safe underground bike storage
Gratis oder Vergünstigte Mahlzeiten
- Subsidized company restaurant
Snacks & Getränke
- In-house cafes
Gesundheits- & Fitnessangebote
- 360m2 company gym
- Fitness program
Team Events & Ausflüge
- Regular after work events
- Team and company events
Weiterbildungsangebote
- Comprehensive training
- Continuing education opportunities
Über das Unternehmen
Brainlab
Branche
Healthcare
Beschreibung
The company develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments.
Noch nicht perfekt?
- Ipsen Pharma GmbH
Senior Medical Lead - New Launches(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - Baxter Medical Systems GmbH + Co. KG
Senior Manager Medical Affairs(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - Denk Pharma GmbH & Co. KG
Teamlead International Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - ImFusion GmbH
Senior Quality Management and Regulatory Affairs Manager(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - ARES Recruiting GmbH
Teamleiter Clinical Specialist TAVI(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenMünchen