Post Market Surveillance Specialist
vor 3 Monaten
**Summary**
This position serves as a point of contact for medical/clinical issues and is responsible for providing expertise for post-market surveillance activities as well as creating and updating PMS relevant documentation.
**Primary Responsibilities**
- Regular update of PMS SOPs based on MDR requirements, guidance documents (MDCGs) and/or (international) regulatory requirements (MDSAP, ROW)
- Provision and timely update of PMS documents
- Overview of all PMS documents and the respective revision status across Novanta business units
- Collection, evaluation and updating of PMS relevant data received from other departments, e.g. Complaint and Product Management
- Conduct literature searches and reviews in according to MDR/MEDDEV 2.7.1 rev. 4
- Provide searches in relevant vigilance databases
- Support for risk analysis and assessment of benefit-risk-ratio
- Collection, evaluation and preparation of customer data for PMS
- Preparation of data for forwarding to customers for their own PMS
**General Tasks **
- Strict compliance with the quality, occupational safety and environmental regulations.
- Implementation of the instructions of the quality / environmental management representative and the occupational safety specialist.
**Required Experience, Education, Skills, Training and Competencies**
- University degree in life science/natural science or an equivalent qualification
- Professional experience in the medical device environment or another regulatory field of work
- Knowledge in regulatory requirements, MDR and relevant MDCGs, rel. MEDDEVs
- Experience in literature search and review required as well as knowledge of regulatory medical writing - Knowledge of database management
- Open and competent attitude when working with your stakeholders
- Fluent in English and German (GER B2) language skills.
- Ability to coordinate complex workflows - Structured and systematic working approach
**Travel Requirements**
- Attendance on conferences, conferences and trade shows
- Willingness to travel to all Novanta locations and business contacts
**Physical Requirements**
- none
Art der Stelle: Vollzeit, Festanstellung
Gehalt: 26.052,48€ - 91.198,69€ pro Jahr
Arbeitszeiten:
- Gleitzeit
- Montag bis Freitag
Leistungen:
- Betriebliche Altersvorsorge
- Betriebliche Weiterbildung
- Betriebsarzt
- Empfehlungsprogramm
- Erfolgsbeteiligung
- Firmenevents
- Firmenhandy
- Flexible Arbeitszeiten
- Homeoffice-Möglichkeit
- Kinderbetreuung
- Kostenlose Getränke
- Kostenloser Parkplatz
- Zusätzliche Urlaubstage
Sonderzahlung:
- Zusatzzahlungen
Arbeitsort: Vor Ort
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