Hologic is the market leader in the women’s health industry withthree different divisions, all offering unparalleled diagnostic and treatmentsolutions.
In the regulated markets where businesses are awarded on a tenderbasis, our capability to win the deal comes from seamless combination ofCustomer solution definition (Commercial and Technical content) together withflawless execution of all tender requirements (Administrative content andprocess).
JOB SUMMARYThe Post Market Surveillance Analyst (PMS) will beresponsible for all aspects of post market surveillance for his assignedbusiness unit.
The PMS Analyst will monitor complaint intake process and verifyif all complaint files are completed according the applicable procedures andregulations.
This individual is also responsible for evaluationand reporting of safety events to competent authorities, development ofstandardize complaint and vigilance reports.
The PMS Analyst will follow-up andcoordinate investigations with the manufacturing plants.ROLE ESSENTIAL DUTIES AND RESPONSIBILITIESFor each customer complaint : Interpret and apply regulations to existingproducts to ensure compliance with vigilance and reporting requirements in allOUS markets.
Verify the content of the complaint file to ensurecompliance with the procedures and applicable regulationsApply the different coding levels for trending andreporting.
Ensure the general complaint handling process isdone accurately (opening verifying closing)In Addition : Assist in complaint trending activities.
Assist in the creation of PSURs (Periodic SafetyUpdate Reports)Assist in the Quality Management Review meetingsand give input if needed.
Support business in customer feedback.Participate in global complaint handling, fieldaction and reporting teams.Write and / or edit vigilance / reporting documents orcreate new templates in compliance with corporate procedures.
Interface with competent authorities and regionalteams to coordinate field actions OUS.Ensure health hazard assessments are performed forregulatory reporting of product problems according to regional requirements.
Provide monthly reporting to regional andinternational management on the status of complaint investigations, vigilancereporting and field action closures.
EDUCATION AND EXPERIENCERelatable Bachelor’s degree in biological sciences,life sciences or related discipline with the required skills, knowledge andabilities that are typically acquired through experience in medical device orpharmaceutical industries within a complaint handling role is desirable.
Technical knowledge of medical imaging (X-ray) wouldbe an advantageFluent in English both written and verbal,professional level French, Spanish or German would also be an advantage.
Knowledge of applicable regulations and standardsrelated to medical device internationally. (ISO-13485, MDR, CFR803, CFR820, ) Ability to independently plan, execute, and / orproblem solve moderate to complex situations.
Ability to exercise judgment within generallydefined practices and policies in selecting methods and techniques forobtaining solutions.
Ability to manage multiple projects.