Product Surveillance Associate I

About CooperSurgical

CooperSurgical is a leading fertility and womens healthcare company dedicated to putting time on the side of women babies and families at the healthcare moments that matter most in life. As a division of CooperCompanies were driven by a unified purpose to enable patients to experience lifes beautiful moments. Guided by our shared values dedicated innovative friendly partners and do the right thing our offerings support patients throughout their lifetimes from contraception to fertility and birth solutions to womens and family care and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers including testing and treatment options as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at.

Work location: North Tonawanda NY; Trumbull CT; or Livingston NJ (on-site)

Scope:

The Product Surveillance Associate I supports post market surveillance activities for combination drugdevice products in compliance with applicable U.S. and international regulatory requirements including 21 CFR Partsand ISO 13485. This role focuses on the execution documentation and support of product complaint investigations and post market surveillance activities to help ensure product safety performance quality and regulatory compliance throughout the product lifecycle and works crossfunctionally with team members Product Surveillance Engineers and Quality leadership to identify potential risks support appropriate escalation and remediation activities and maintain accurate inspectionready records that support the organizations Quality Management System and regulatory obligations.

Job Summary:

The Product Surveillance Associate I is responsible for performing documenting and supporting timely and compliant product complaint investigations for combination drugdevice products. This position evaluates post market information to support assessments of product performance patient safety and regulatory impact and assists in determining whether escalation activities such as CAPA initiation Health Hazard Evaluations trending or regulatory reporting may be required and partners with Quality Regulatory Affairs R&D Manufacturing Medical Affairs and Supply Chain to support root cause analysis activities followup actions and verification of corrective actions under defined procedures and supervision. This role helps ensure post market surveillance and complaint records are accurate complete and compliant and supports internal and external audits while contributing to the continuous improvement of post market surveillance and Quality Management System processes.

• Executes and supports product complaint investigations in accordance with approved procedures and under guidance from Product Surveillance Engineers or Quality leadership.
• Performs and documents thorough timely and compliant investigations including data collection product history review and preliminary assessments of product performance and potential patient impact.
• Supports risk assessments by gathering data documenting risk considerations and assisting with evaluation of investigation outcomes to support escalation decisions (e.g. CAPA HHE trending regulatory reporting).
• Assists with root cause analysis activities by applying basic structured investigation tools and supporting crossfunctional discussions.
• Supports followup activities related to corrective and preventive actions including documentation milestone tracking and effectiveness check support as assigned.
• Maintains complete accurate and traceable complaint and post market surveillance records within designated systems; monitors assigned investigation timelines and communicates status updates.
• Ensures documentation is clear objective contemporaneous and compliant with internal procedures and regulatory requirements to support inspection readiness.
• Provides support during internal and external audits and inspections including documentation retrieval and responses related to complaint handling and post market surveillance.
• Participates in continuous improvement initiatives related to post market surveillance and QMS processes through feedback data review and procedural adherence.
• Escalates issues delays or potential risks to senior team members or management as appropriate.
• Perform other duties as assigned.

Travel:This position may require 5% domestic and/or international travel.

Knowledge Skills and Abilities:

• Working knowledge of FDA Quality System and pharmaceutical regulations including 21 CFR Parts 211 and 820 as they relate to complaint handling and post market surveillance.
• Demonstrated ability to follow defined procedures and perform welldocumented compliant investigations.
• Basic understanding of risk assessment principles and escalation pathways (e.g. CAPA HHE trending) with ability to recognize when to seek guidance.
• Strong written and verbal communication skills to clearly document findings and communicate investigation status to crossfunctional partners.
• Good analytical and organizational skills with the ability to manage multiple investigations and meet assigned timelines.
• High attention to detail and strong data management skills with commitment to accurate recordkeeping and compliance.
• Ability to work effectively within crossfunctional teams and follow direction from senior team members.
• Experience supporting internal/external audits related to complaint handling or post market surveillance is a plus.

Work Environment:

• Office/Production/Clean Room/Warehouse Environment which may require long periods of sitting standing or getting up and down throughout the day.
• Occasionally lift to 35 pounds.

Experience:

• 2 years of experience working in manufacturing environment preferably within a pharmaceutical and/or medical devices related field
• 1 years of experience supporting product complaint investigations post market surveillance or quality activities within a regulated pharmaceutical medical device or combination product environment.

Education:

• Bachelors degree in a Health Engineering or Science field preferred.

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Our Benefits:

As an employee of CooperSurgical youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package medical coverage 401(k) parental leave fertility benefits paid time off for vacation personal sick and holidays and multiple other perks and benefits. Please visit us atto learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender gender identity or expression or veteran status. We are proud to be an equal opportunity workplace.

For U.S. locations that require disclosure of compensation the starting base payfor this role is between$60000.00 - $75000.00 annually. Theactual base payincludes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.