Senior Vigilance Specialist

Are you driven by patient safety? Do you thrive in a global environment, collaborating with internal and external stakeholders? Join us in our mission to make life easier for people living with intimate healthcare conditions. We are looking for a resourceful and proactive Senior Vigilance Specialist to strengthen our Post Market Surveillance team.

Why this role matters

As a Senior Vigilance Specialist, you play a critical role in safeguarding user safety and ensuring compliance with global regulations. Our ability to market and sell products depends on rigorous safety assessments—both proactively and through continuous monitoring of market feedback.

Join our team 

The position is in Coloplast headquarter in Humlebæk. Joining us, you will be part of a hybrid team of 6 Vigilance specialists, where 2 are in headquarter and 4 are at our Business Center in Poland. In headquarter you will be part of a team consisting of highly qualified colleagues supporting different aspects of quality (Post Market Surveillance, Vigilance, Global Systems and Global Processes). Together, we are responsible for bringing expert knowledge into the entire Coloplast organization.

Your main responsibilities will be to diligently investigate incidents and report to national competent authorities according to applicable regulatory guidelines and timelines. Furthermore, you will create post market surveillance documents, like PSUR and PMS reports.

Your key responsibilities:

• Supervise high-risk cases and adverse events, while mentoring Vigilance Specialists across all Business Areas. 
• Maintain an overview of PSUR/PRER/PMSR and ensure timely compliance. 
• Provide input to Quality Management Reviews with accurate vigilance data and statistics. 
• Develop, maintain, and review Post Market Surveillance (PMS) Plans aligned with product risk profiles and regulations. 
• Manage Field Safety Corrective Actions (FSCA) / Recalls per internal procedures and regulatory requirements. 
• Contribute to complex projects, delivering in line with objectives and corporate strategy. 
• Analyze internal and external data for Vigilance Intelligence System (VIS) to identify trends, risks, and country-specific reporting criteria. 
• Support internal and external audits and inspections with documentation, case insights, and vigilance expertise. 
• Act as primary liaison for vigilance matters, ensuring timely communication with Notified Bodies for compliance and safety. 
• Monitor evolving regulatory requirements and translate them into actionable internal processes aligned with global vigilance standards.

Your qualifications

Essential:

• Bachelor or Master degree in life sciences, engineering, pharmacy, nursing or similar 
• 8+ years of experience in Vigilance, Post Market Surveillance, Regulatory Affairs or Quality Affairs 
• Solid understanding of medical device regulations and vigilance processes 
• Expert knowledge of medical terminology and/or clinical documentation 
• Expert knowledge of relevant standards and legislation (ISO13485, Medical Device Regulation, FDA-part 820, Health Canada Device regulations, Japanese QMS for Devices) with special focus on regulations for Vigilance 
• Proven experience in handling complex cases and regulatory submissions 
• Strong leadership, mentoring and cross-functional collaboration skills. 

Preferred: 

• Prior involvement in audits or inspections as a subject matter expert 
• Experience leading process improvement and harmonization initiatives 
• Advanced use of QMS tools, regulatory databases and global vigilance frameworks 

You are a collaborative team player with a positive, adaptable mindset and a clear focus on achieving shared goals. Proactive and results-oriented, you combine a constructive approach with strong planning and execution skills to deliver on time. You thrive in a dynamic environment, managing multiple tasks simultaneously while maintaining an analytical perspective. Your ability to interpret complex data without losing sight of the bigger picture sets you apart.

Interested?

If you are a strategic thinker with a passion for process optimization, innovation, and global collaboration, we encourage you to apply. The position will remain open until a suitable candidate is found, so please don’t hesitate to submit your application through the system and Handan Yildiran, Head of Post Market Surveillance, Systems & Processes will evaluate continuously. 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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