Medical Device Reporting Specialist (f/m/d)
W.L. Gore & Associates
About the Role: Calling all champions of safety and superheroes of compliance! As a Medical Device Reporting Specialist (f/m/d) at Gore you're not just ensuring regulations are met – you're the guardian of patient safety in the world of medical devices. Your mission? To manage the reporting of adverse events and product complaints with precision and speed, ensuring our devices continue to make a positive impact.
This position will be located at our facility in Putzbrunn near Munich, Germany, with work from home days possible as part of a hybrid arrangement, depending upon the responsibilities of the role and business needs.
- Determine regulatory reportability for medical device incidents for class II and III devices (MDR (EU) 2017/745 and CFR 803)
- Prepare and Submit Manufacturer Incident and Medical Device Reports as required per EU MDR and FDA regulations
- Analyze incidents to determine classification and similar incidents
- Determine medical device problem, health effects, and cause investigations IMDRF codes
- Review and summarize investigation results and remedial actions taken by manufacturer, healthcare facility, patient or user subsequent to the incident
- Collaborate with Regulatory Affairs and other functions to support risk assessments, regulatory projects, process improvement and regulatory responses
- Develop metrics for operational targets to monitor and evaluate regulatory compliance
- Closely monitor and communicate performance to metrics, including insight into trends, alerts, and actions
- Provide regulatory input for product recalls, recall communications, and CAPAs (where necessary)
Required Qualifications:
- At least 1 year of professional experience in the medical device industry and a Bachelor's degree in a related disciplines or clinical professionals, who are looking for a career change into the industry
- Professional experience in medical device regulation, quality assurance (e.g., MDR (EU) 2017/745, ISO 13485) and/or clinical knowledge
- Excellent communication and interpersonal skills
- Exceptional organizational abilities with a keen attention to detail
- Ability to work effectively both independently and as part of a team
- Very good written and spoken communication skills in English and German
- Confident use of MS Office tools
- Occasional travelling e.g. trainings, meetings (up to 5%)
Desired Qualifications:
- Proven experience in supporting audits or regulatory response communications with successful outcomes
- Professional experience in medical coding or a related field
- Experience with the SmartSolve Complaint Management System and EUDAMED
Remote Working Arrangements are permitted for Associates, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed.
What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits
We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
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