Post Market Surveillance Analyst EMEA
Hologic
- Zaventem, Vlaams Brabant
- Contract
- Voltijds
- 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).
- Participate in quality audits and inspections as a subject matter expert.
- 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.
- 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.