Segula Technologies
Electrical Test Engineer(m/w/x)
Freelance
Vollzeit
Berufserfahren
Keine Angabe
Bautzen
ON
Ontex Group NV13 Tage
Group Regulatory Affairs Specialist Class II(m/w/x)
Vollzeit
Berufserfahren
Keine Angabe
Großpostwitz/O.L.
Nejo KI-Zusammenfassung
In this role, you will navigate the complex regulatory landscape, ensuring product compliance from development to post-market. You will collaborate with cross-functional teams, provide guidance on regulatory requirements, and stay updated on scientific advances that shape healthcare regulations.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
Anforderungen
- •Master’s degree in science or equivalent experience
- •In-depth knowledge of US and Canada regulations for medical devices
- •Knowledge of medical device regulations in Central America, South America (Brazil)
- •Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971
- •Certifications in regulatory affairs like RAC
- •Fluency in English and any other language
- •Minimum of 3 years experience in Regulatory Affairs for medical devices
- •Experience in 510k submission
- •Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
- •Experience in working with cross-functional teams
- •Ability to integrate and demonstrate core values, integrity and accountability
- •Ability to lead, manage, collaborate and communicate within the organization
Master-Abschluss
Berufserfahrung
3 Jahre
Deine Aufgaben
- •Research regulatory requirements for submissions and compliance
- •Monitor the regulatory environment and provide innovative advice
- •Supervise data input activities and analyze impact reports
- •Identify needs for new regulatory procedures and develop SOPs
- •Assess market access requirements and potential obstacles
- •Evaluate preclinical, clinical, and manufacturing documents
- •Provide regulatory input on global requirements to product teams
- •Advise stakeholders on regulatory requirements for quality data
- •Collaborate with cross-functional teams on regulatory interactions
- •Communicate with regulatory authorities during submissions
- •Submit relevant reports to regulatory authorities during research
- •Notify authorities about product safety issues for compliance
- •Support inspections and audits with regulatory input
- •Submit changes and updates to regulatory authorities
- •Ensure post-market regulatory requirements are met
- •Improve quality of policies and services provided
- •Maintain knowledge of evolving regulatory information systems
- •Assist in developing and monitoring departmental budgets
- •Identify vital resources for project teams
- •Track scientific advances impacting product development
- •Participate in education and studies to meet regulatory needs
- •Engage in stakeholder groups for science-based decision-making
Sprachen
Englisch – verhandlungssicher
Deine Vorteile
Boni & Prämien
- •Holiday and Christmas bonuses
Mehr Urlaubstage
- •30 days of holiday
Betriebliche Altersvorsorge
- •Company pension scheme
Mitarbeiterrabatte
- •Corporate benefits and discounts
Abwechslungsreiche Aufgaben
- •Exciting and varied working environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Ontex Group NV 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.
Ähnliche Jobs direkt in deine Inbox?
Noch nicht perfekt?