An Insightful Interview with Heather Hagvik
What would you like to share about your role at Magle Group?
In my role as Senior Regulatory at Magle Group, I am responsible for overseeing regulatory compliance for our medical devices, ensuring adherence to both the Medical Device Directive (MDD) and the newer Medical Device Regulation (MDR).
My primary focus is on regulatory strategy, where I led the regulatory pathways for our devices, aligning them with evolving European standards to maintain market access and competitiveness.
How do you envision your role as a Senior Regulatory Specialist contributing to advancements in healthcare?
As a Senior Regulatory Specialist, I envision my role as a critical contributor to the advancement of healthcare by ensuring that medical devices not only meet rigorous regulatory standards but also deliver safe, effective, and innovative solutions to patients.
By navigating the complexities of both the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) frameworks, I would facilitate the seamless transition of products from concept to market, thus accelerating access to life-enhancing technologies.
Ultimately, my goal as a Senior Regulatory Specialist would be to uphold the highest standards of regulatory excellence, driving product innovations that not only comply with MDD and MDR requirements but also contribute to improved patient outcomes and overall healthcare quality.
In your opinion, how does applying the IMPACT (strategy emphasizes Innovation, Motivation, Positivity, Accountability, Customer-centricity, and Teamwork) strategy improve work processes and overall performance?
Applying the IMPACT strategy significantly enhances work processes and overall performance by fostering a culture of innovation, accountability, and collaboration that drives both individual and team success.