Post Market Surveillance Manager

3Shape A/S; København; Vor Ort; DKK 900.000 - 1.100.000; Vollzeit

Benefits dieser Stelle

Office in downtown Copenhagen

Informal atmosphere and diverse team

Professional challenge in global MedTe

Zusammenfassung

3Shape A/S in Copenhagen is seeking a Post-Market Surveillance Manager to lead PMS activities across EU MDR, FDA and ISO standards. You will collaborate with Regulatory Affairs, Product Creation, and Product Management to ensure continued product safety and performance.

The role involves developing PMS plans and reports, monitoring post-market data, and presenting findings to senior leadership. We offer an engaging, globally oriented environment with empowerment over tasks and a strong emphasis

Qualifikationen

• Master's degree in Life Sciences, Engineering, Biomedical Sciences, Public Health, Healthcare, or related field
• Relevant Quality, Regulatory or Vigilance operational experience from the medical device industry
• Knowledge of EU medical device regulations/directives, including ISO-13485 and ISO-14971
• Excellent planning, cooperation, and communication skills
• Basic AI knowledge preferable within tools used for PMS, Vigilance and trending
• Basic statistical knowledge

Aufgaben

• Lead and maintain the PMS program in accordance with EU MDR, FDA, ISO 13485, and other global requirements
• Develop and maintain PMS Plans, PMS Reports, PSURs, PMCF reports, and trend analyses
• Monitor and evaluate complaints, adverse events, customer feedback, and other post-market data sources
• Identify safety and performance trends and support risk management activities
• Collaborate with Regulatory Affairs, Product Creation, and Product Management to drive product improvement
• Lead vigilance assessments and regulatory reporting activities for adverse events, serious incidents, and FSCAs
• Manage submissions and maintenance of regulatory documentation within EUDAMED
• Assist with audits and inspections
• Present PMS findings and recommendations to cross-functional teams and senior leadership

Jobbeschreibung

Are you ready to pursue your career within disruptive MedTech working with 3D scanners and software medical devices in a global setting? Then 3Shape offers a unique opportunity to work as Post-Market Surveillance Manager in the center of Copenhagen at Kongens Nytorv.

About the department

You will report to the Head of Scientific Affairs and you will be part of our growing global RA organization based in Copenhagen, which currently includes around 30 people. You will interact with a wide range of stakeholders and especially with Product Creation, Customer Support, Product Management, Global Sales, Resellers, and external consultants worldwide. You will assist with developing the future of disruptive MedTech in collaboration with the entire organization and enable people across the world to enjoy better lives.

Your new job in 3Shape

As our new Post-Market Surveillance Manager (PMS) you will lead and facilitate PMS activities in accordance with relevant global regulations to support our products with regard to safety and performance.

Your key responsibilities

• Lead and maintain the company's PMS program in accordance with EU MDR, FDA, ISO 13485, and other global requirements.
• Develop and maintain PMS Plans, PMS Reports, PSURs, PMCF reports, and trend analyses.
• Monitor and evaluate complaints, adverse events, customer feedback, and other post-market data sources.
• Identify safety and performance trends and support risk management activities.
• Collaborate with Regulatory Affairs, Product Creation, and Product Management to drive continuous product improvement.
• Lead vigilance assessments and regulatory reporting activities for adverse events, serious incidents, and field safety corrective actions (FSCAs), ensuring compliance with global medical device regulations.
• Manage submissions and maintenance of regulatory documentation within EUDAMED.
• Assist with audits and inspections
• Present PMS findings and recommendations to cross-functional teams and senior leadership.

Your profile

We are looking for a person with:

• Master's degree in Life Sciences, Engineering, Biomedical Sciences, Public Health, Healthcare, or related field
• Relevant Quality, Regulatory or Vigilance operational experience from the medical device industry
• Knowledge of EU medical device regulations/directives, including ISO-13485 and ISO-14971
• Excellent planning, cooperation, and communication skills
• Basic AI knowledge preferable within tools used for PMS, Vigilance and trending
• Basic statistical knowledge

As a person, you are a good team player with strong interpersonal skills who thrives working with multiple stakeholders and partners, both internally and externally. Also, you have the ability to successfully handle multiple tasks while managing tight deadlines.

We offer:

• An attractive office environment in downtown Copenhagen, next to Kongens Nytorv
• An inspiring work environment in an informal atmosphere, with social, diverse, and highly skilled colleagues
• A professional challenge in a dynamic, globally-oriented business environment
• Empowerment and influence over your own tasks

We are committed to celebrating human diversity, and we trust that the best way to reach outstanding business results, is by welcoming diverse people into our community.

About us

3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Twenty years later, 3Shape has 2,000+ employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on LinkedIn.