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Post-Market Surveillance Analyst

San Diego, CA, United States

Job Summary

Our Post-Market Surveillance Analyst is responsible for creating and maintaining Post Market Surveillance (PMS) activities for Hologic's Diagnostic Solutions Division (Molecular, Cytology, and Perinatal). This role ensures compliance with applicable regulations, including but not limited to, EU IVDR and Health Canada Summary Reports. The Analyst will work collaboratively with cross-functional teams to support product safety, regulatory compliance, and help drive continuous improvement.

Key Accountabilities and Responsibilities

+ Create and maintain the Diagnostics global post market documentation for EU In Vitro Diagnostic Medical Device Regulation (IVDR) PMS Reports (PMSR), Periodic Safety Update Reports (PSUR), Post-Market Performance Follow-Up (PMPF), Summary of Safety and Performance (SSP), IVDR Technical Documentation and Health Canada Summary Reports (HCSR) ensuring timely completion and compliance with applicable regulatory requirements

+ Collect and analyze global PMS data from complaints, CAPAs, sales, reportable events, trends recalls and incident reporting. Assessing reasons, severity, and lots impacted.

+ Assess and submit a trend report for any statistically significant increase in the frequency or severity of non-incidents.

+ Perform searches for adverse events and recalls from public databases for Hologic and similar devices

+ Analyze the results for applicability to Hologic and/or similar device for inclusion/exclusion decision making.

+ Evaluate report results for updates to the risk-benefit determination and to determine if any additional activities are required.

+ Summarize all relevant inputs for EU IVDR post market documentation ensuring clear, concise and well-written reports are generated.

+ Facilitate document reviews and manage approvals within the QMS. · Maintain updates to applicable procedures and templates as needed.

+ Maintain an understanding of global medical device regulations with a focus on EU IVDR and Health Canada Summary Report requirements.

+ Develop a deep knowledge of Hologic diagnostic products.

+ Interact/coordinate with and support other departments and SMEs as needed.

+ Clearly and effectively communicate results and conclusions to stakeholders as needed.

+ Perform other function-related activities in addition to the above-mentioned responsibilities as reasonably required by business needs.

Required Qualifications and Experience

+ Bachelor’s degree, preferably in a science, engineering, or a healthcare-related field

+ Knowledge of regulations for In-Vitro Diagnostic Regulation (2017/746) and Health Canada regulations is strongly desired.

+ Experience writing IVDR related documentation is highly desired.

+ Understanding of QSR & ISO requirements.

+ Prior experience processing medical device or drug complaints, CAPAs, and reportable events is preferred.

+ Excellent technical writing skills, analytical skills, and ability to communicate and present technical information.

+ Effectively prioritize work and keep track of deadlines to align with set schedules.

+ Excellent communication skills and ability to collaborate with intra- and inter-departmental team and stakeholders.

+ Must work well as part of a team.

+ Strong organizational and interpersonal skills, attention to detail, and ability to focus in a fast-paced environment are essential.

+ Self-starter and eager to continue learning

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow and giving you the tools and knowledge you need to succeed in your role.

From a benefits perspective, you will join our wide-ranging benefits policy including PTO, Employee Stock Purchase Plans, exciting Employee Wellness plans and many more.

The annualized base salary range for this role is $91,200 - $142,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

_Agency And Third Party Recruiter Notice_

_Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered._

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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