Post Market Surveillance Analyst Emea

Il y a 7 mois


Zaventem, Belgique Hologic Temps plein

**Here at Hologic it is our purpose to enable healthier lives everywhere, every day.**

**We are driven by our passion to become the global champion for women’s health.**

**We achieve this by fulfilling our promise to bring The Science of Sure to life**.

Are you passionate about making a difference in the world of healthcare? Your quality background could enable you to help us ensure the safety and efficacy of our portfolio.

We are seeking a highly motivated **Post Market Surveillance Analyst** to join our dynamic team for a 12-month fixed-term contract. 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-market surveillance 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).

**What You Will Bring**:

- Bachelor’s degree in a scientific or engineering discipline.
- Proven experience in post-market surveillance 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



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