Penumbra
Clinical Specialist(m/w/x)
Vollzeitmit HomeofficeSenior
Würzburg, Erlangen, Nürnberg, Mannheim, Stuttgart
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Shaping regulatory strategy for clinical trial technologies across global markets. FDA 21 CFR 820, ISO 13485, and international regulations knowledge required. Flexible working hours, support for professional development.
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Anforderungen
- Master’s degree in Engineering, Life Sciences, or related technical field
- 6+ years medical device industry experience
- 4+ years Regulatory Affairs experience (medical devices/pharmaceuticals)
- 3+ years proven leadership experience managing/guiding teams
- Strong knowledge of FDA regulations, ISO standards, global medical device requirements
- Experience interacting with regulatory authorities, supporting audits/inspections
- Understanding of clinical trial environments and GCP highly desirable
- Excellent analytical, organizational, and communication skills
- Fluency in English and German
- Detail-oriented with strong problem-solving capabilities
- Ability to manage complex regulatory challenges
Aufgaben
- Ensure innovative clinical trial technologies meet global regulatory standards
- Shape regulatory strategy across the full product lifecycle
- Guide cross-functional teams to ensure compliance with regulatory standards
- Lead global regulatory activities for FDA 21 CFR 820, ISO 13485, and international regulations
- Partner with Product Management, Logistics, and Engineering for compliant product development
- Establish and optimize global trade compliance processes
- Mentor hardware and software development engineers on regulatory matters
- Assess regulatory impact of changes to design, materials, labeling, software, and suppliers
- Support FDA 510(k) filings and international product registrations
- Review and approve product labeling, technical documentation, and marketing materials
- Participate in internal, external, and vendor audits
- Contribute to corrective and preventive action initiatives
- Act as Person Responsible for Regulatory Compliance (PRRC) under MDR requirements
- Oversee development and maintenance of SOPs and work instructions
- Support post-market surveillance and vigilance reporting
- Drive continuous improvement activities
Berufserfahrung
6 Jahre
Ausbildung
Master-Abschluss
Sprachen
Englisch – fließend
Deutsch – fließend
Tools & Technologien
FDA regulationsISO standards510(k) submissionsMDR
Benefits
Flexibles Arbeiten
- Flexible working hours
- Working time accounts
Weiterbildungsangebote
- Support professional development
- Internal and external training
- Certification programs
Sonstige Vorteile
- Engaging employee programs
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Clario erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei ClarioÜber das Unternehmen
CL
HealthcareEstenfeld
The company transforms lives by unlocking better evidence to advance clinical science and bring life-changing therapies to patients faster.
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