W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSenior
Berlin
Neuer Job?Nejo!
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NONovanta
Regulatory Affairs Specialist(m/w/x)
Berlin
VollzeitVor OrtJunior
Nejo KI-Zusammenfassung
Ensuring product compliance with global regulations for mission-critical healthcare and manufacturing components. 1-2 years of relevant experience and strong problem-solving skills required. Focus on registration-document compilation for third countries.
Anforderungen
- 1-2 years relevant professional experience
- Extensive research ability, in-depth knowledge, creativity
- Complex problem anticipation, identification, definition, and solving
- General manufacturing process knowledge
- Quality-consciousness, trustworthiness, reliability
- Team player skills
- Communicative skills
- Structured and systematic working method
- Independent English use (CEFR-B2)
Aufgaben
- Ensure product compliance with regulations and guidelines
- Evaluate regulations and guidelines
- Liaise with regulatory authorities
- Guide internal teams on regulatory matters
- Compile registration-relevant documents for third countries
- Prepare free sales certificates, legalizations, and other declarations
- Compile documents for Notified Body documentation tests
- Support control and acceptance of technical documentation
- Assess compliance with Essential Requirements
- Prepare and release declarations of conformity
- Participate in risk management process implementation
- Conduct clinical evaluations and usability file reviews
- Elaborate and update design guidance procedures
- Review and approve regulatory documents
- Review Risk Analysis and Risk Management documents
- Evaluate Clinical Evaluation, Design Validation, and Design Verification Plans
- Review Software Documentation, Instructions for Use, and Product Labels
- Process change requests and check approval relevance
- Assist with general regulatory inquiries
- Serve as interface to customer RA departments
- Coordinate and cooperate with Notified Body and authorities
- Accompany audits from customers, authorities, and suppliers
- Participate in QMS maintenance measures
- Adapt processes to maintain QMS
- Participate in the innovation process
- Comply with quality, occupational safety, and environmental regulations
- Implement instructions from quality and environmental management
- Make decisions and provide solutions to complex problems
- Act as a consultant to less experienced personnel
- Train less experienced personnel
Berufserfahrung
- 1 - 2 Jahre
Ausbildung
- Matura
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novanta 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.
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NONovanta
Regulatory Affairs Specialist(m/w/x)
Berlin
VollzeitVor OrtJunior
Nejo KI-Zusammenfassung
Ensuring product compliance with global regulations for mission-critical healthcare and manufacturing components. 1-2 years of relevant experience and strong problem-solving skills required. Focus on registration-document compilation for third countries.
Anforderungen
- 1-2 years relevant professional experience
- Extensive research ability, in-depth knowledge, creativity
- Complex problem anticipation, identification, definition, and solving
- General manufacturing process knowledge
- Quality-consciousness, trustworthiness, reliability
- Team player skills
- Communicative skills
- Structured and systematic working method
- Independent English use (CEFR-B2)
Aufgaben
- Ensure product compliance with regulations and guidelines
- Evaluate regulations and guidelines
- Liaise with regulatory authorities
- Guide internal teams on regulatory matters
- Compile registration-relevant documents for third countries
- Prepare free sales certificates, legalizations, and other declarations
- Compile documents for Notified Body documentation tests
- Support control and acceptance of technical documentation
- Assess compliance with Essential Requirements
- Prepare and release declarations of conformity
- Participate in risk management process implementation
- Conduct clinical evaluations and usability file reviews
- Elaborate and update design guidance procedures
- Review and approve regulatory documents
- Review Risk Analysis and Risk Management documents
- Evaluate Clinical Evaluation, Design Validation, and Design Verification Plans
- Review Software Documentation, Instructions for Use, and Product Labels
- Process change requests and check approval relevance
- Assist with general regulatory inquiries
- Serve as interface to customer RA departments
- Coordinate and cooperate with Notified Body and authorities
- Accompany audits from customers, authorities, and suppliers
- Participate in QMS maintenance measures
- Adapt processes to maintain QMS
- Participate in the innovation process
- Comply with quality, occupational safety, and environmental regulations
- Implement instructions from quality and environmental management
- Make decisions and provide solutions to complex problems
- Act as a consultant to less experienced personnel
- Train less experienced personnel
Berufserfahrung
- 1 - 2 Jahre
Ausbildung
- Matura
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novanta 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Novanta
Branche
Healthcare
Beschreibung
The company powers technology products that transform healthcare and advanced manufacturing, enhancing productivity and lives.
Noch nicht perfekt?
- W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - 6280 TIB Molbiol Syntheselabor GmbH
Regulatory Affairs Manager(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenBerlin - W.O.M. World of Medicine GmbH
Medical Affairs Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin