Senior Post Market Suveillance Analyst

pSenior Post Market Suveillance Analyst /p pZaventem, Vlaams Brabant, Belgium /p pAs a leading innovator of women's health, we at Hologic are empowering people to live healthier lives everywhere, every day. /p pOur Quality teams play a critical role in protecting patients, customers and our business by ensuring we meet the highest standards of quality, compliance and regulatory excellence. They help us maintain customer trust, support market access, and ensure our products continue to meet global regulatory expectations throughout their lifecycle. /p pAs our bSenior Post Market Surveillance Analyst /b , you will be responsible for key post market surveillance activities, with a particular focus on complaint handling, vigilance reporting and the coordination of Field Safety Corrective Actions across the EMEA region. This is an exciting opportunity to use your technical knowledge, regulatory understanding and stakeholder management skills to make a direct impact on patient safety, compliance and customer confidence. /p h3What to expect: /h3 ul lipCoordinate the implementation of Field Actions, including Field Safety Corrective Actions, across the EMEA region. /p /li lipOversee assigned field actions from initiation through to completion, ensuring timely progress and closure. /p /li lipPrepare required documentation, including FSCA reports, Field Safety Notices, customer lists and related materials. /p /li lipSubmit Field Safety Corrective Actions to Competent Authorities and coordinate follow-up communications. /p /li lipEnsure field action and post market surveillance activities comply with regulatory requirements and internal procedures. /p /li lipParticipate in and lead cross-functional meetings and projects relating to field action activities. /p /li lipManage communication with affected parties, including Hologic employees, dealers and distributors. /p /li lipMaintain knowledge of current and proposed regulations, laws, guidelines, standards and initiatives relating to field actions and post market surveillance. /p /li lipSupport internal and external audits as required. /p /li lipSupport wider post market surveillance activities, including complaint handling and vigilance reporting. /p /li lipFor customer complaints, interpret and apply applicable regulations to ensure compliance with vigilance and reporting requirements. /p /li lipEnsure complaint handling activities are completed accurately from opening through verification and closure. /p /li lipWrite, edit and develop vigilance and reporting documents, templates and related materials in line with corporate procedures. /p /li lipProvide monthly reporting to regional management on complaint investigations, vigilance reporting and field action closures. /p /li lipPerform other related duties as assigned. /p /li /ul h3What we expect: /h3 ul lipbExpertise: /b Bachelor's degree in biological sciences, life sciences or a related discipline. /p /li lipbExperience: /b Experience in the medical device, IVD or pharmaceutical industry, including experience in a field action or complaint handling role. /p /li lipbRegulatory knowledge: /b Understanding of applicable international medical device regulations and standards, such as ISO 13485, MDR/IVDR, CFR 803 and CFR 820, would be preferred. /p /li lipbVigilance

experience:
/b Experience interfacing with Competent Authorities responsible for vigilance activities would be preferred. /p /li lipbCommunication: /b Solid written and verbal communication skills, with the ability to communicate clearly, professionally and effectively with internal teams, external partners and medical personnel. /p /li lipbLanguages: /b Fluency in English is required; working knowledge of another language would be an advantage. /p /li lipbInternational mindset: /b Experience working in an international environment. /p /li lipbAutonomy: /b Ability to independently plan, execute and problem-solve in moderate to complex situations. /p /li lipbJudgment: /b Ability to exercise sound judgment within defined practices and policies when selecting methods and solutions. /p /li lipbCollaboration: /b A team player who demonstrates initiative, balanced assertiveness and professionalism. /p /li lipbOrganisation: /b Ability to manage multiple projects and priorities in a busy environment with competing deadlines. /p /li lipbAdaptability: /b Flexibility to adapt to changing regulatory requirements, business priorities and customer needs. /p /li lipbContinuous Learning: /b Commitment to staying current with evolving regulations, standards, industry expectations and best practices. /p /li /ul h3Why Hologic? /h3 pWe are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required, so we provide comprehensive training when you join, as well as continued development and training throughout your career. /p pWe look forward to hearing from you /p pSalary: €64,000
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