Post Market Surveillance Analyst EMEA > Zaventem > Joboolo BE :
Company : Hologic, Inc. Location : Zaventem Flanders From : Talent BE
Your role is critical to our commitment to patient safety and regulatory compliance.
You will play a key part in monitoring the performance of Hologic’s products post-market release, ensuring that our high standards are upheld across the globe.Your Impact:
Conduct thorough analysis of post-market data, including complaints, incidents, and feedback from customers and stakeholders.
Collaborate with cross-functional teams to assess risk and impact on product quality and patient safety.
Assist in the creation of PSUR’s Assist in Quality Management review meetings, offering input for improvement where needed Participate in global complaint handling, field action and reporting teams Ensure health hazard assessments are perfomrned for regulatory reporting of product problems according to regional requirements Prepare detailed post-marketsurveillance reports and documentation for regulatory submissions and internal use.
Support the implementation of corrective and preventive actions (CAPAs) based on surveillance findings.
Maintain up-to-date knowledge of relevant regulations and guidelines, particularly those related to the EU MDR (Medical Device Regulation).
Participate in quality audits and inspections as a subject matter expert.
What You Will Bring:
Bachelor’s degree in a scientific or engineering discipline.
Proven experience in post-marketsurveillance or quality assurance within the medical device or diagnostics industry.
Familiarity with international regulations and standards, such as IVDR, ISO 13485, FDA QSR, and EU MDR.
Analytical thinker with excellent problem-solving skills and attention to detail.
Strong communication and collaboration skills, able to work effectively in a team environment.
Fluent in English, with proficiency in additional European languages being a plus.
So, why join Hologic? A chance to be part of a globally recognized leader in healthcare.
A stimulating work environment that encourages innovation and personal growth.
Competitive salary and comprehensive benefits package.
Hologic is a global leader in women's health, with a mission to deliver life-changing diagnostics, surgical, and medical imaging solutions.
Our innovative technologies are designed to enable healthier lives everywhere.
We believe in fostering a collaborative environment where each member's contribution is vital to our success.Join us today and be a part of shaping the future of global healthcare.
Your expertise is invaluable, and together, we can make a difference!#LI-HE1 Hologic,Inc. ZaventemFlanders
