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Post Market Surveillance (PMS) Specialist Medical Devices (m/f/d)

Novanta -
Berlin

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Details zur Stelle

Vollzeit

Qualifikationen

Qualitätsmanagement

Vollständige Stellenbeschreibung

Build a career powered by innovations that matter! At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people’s lives and redefining what’s possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications—from minimally invasive surgery to robotics to 3D metal printing.

Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific. Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment. Come explore Novanta.

Business Unit Overview

This position is part of Novanta’s Advanced Surgery business unit group. Novanta offers highly reliable, precise and safe solutions that enhance system performance and improve patient outcomes. Insufflators, pumps and disposable tube sets, along with medical visualization and operating room integration technologies are the preferred solution for minimally invasive surgery applications.

Summary

This position serves as a point of contact for medical/clinical issues and is responsible for vigilance as well as Post-Market surveillance and Post-Market Clinical Follow-Up activities, focusing on the evaluation of vigilance data, reporting adverse events and performing recalls/FSCAs and/or corrective actions.

Your Responsibilities

Evaluation of adverse events based on the event description and medical device investigation results
Provision of a decision on reporting obligations based on international regulatory requirements
Reporting of adverse events in line with country-specific requirements
Search and evaluation of vigilance data for medical devices using country-specific databases
Support with risk analysis and assessment of benefit-risk-ratio
Provision of a significant input in Health-Risk Assessments
Provision of a decision on recall/FSCA obligations based on international regulatory requirements
Creation of recall/FSCA related documentation
Point of contact for inquiries from authorities and vigilance related customer interactions
Regular update of Vigilance related SOPs based on MDR requirements, guidance documents (MDCGs) and/or (international) regulatory requirements (MDSAP, ROW)
Provision and timely update of PMS and/or PMCF documents
Conduct literature searches and reviews in according to MDR/MEDDEV 2.7.1 rev. 4

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, 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 required
Risk assessment and experience in reporting adverse events in line with country-specific requirements required
Knowledge of international regulatory requirements for vigilance activities required
Knowledge of vigilance database management and the evaluation of vigilance data, focusing on the benefit-risk ratio, required
Experience in literature search and review is beneficial as well as knowledge of regulatory medical writing
General QMS knowledge
Open and competent attitude when working with your stakeholders
Fluent written and spoken English, German would be a big plus
Ability to coordinate complex workflows
Structured and systematic working approach
High-quality documentation skills

Travel Requirements

Attendance on conferences, and trade shows
Willingness to travel to all Novanta locations and business contacts

#LI-JM1

#Hybrid

Novanta is proud to be an equal employment opportunity and affirmative action workplace. We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, military and veteran status, disability, genetics, or any other category protected by federal law or Novanta policy.

Please call +1 781-266-5700 if you need a disability accommodation for any part of the employment process.

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