Post Market Surveillance Specialist 1

4 weeks ago

Dublin, Dublin City, Ireland Cook Medical Incorporated Full time
Overview

The Post Market Surveillance Specialist acts as a go-between the Cook manufacturer, Cook local affiliates, and regulatory authorities. Responsible for assessing complaints for Regulatory Reporting, including Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS), field action, and related correspondence to applicable Regulatory bodies.

Reporting to: Team Lead, Post Market Surveillance
Department: Complaints

Learn more about Cook Medical here

Responsibilities
  • Department: Complaints
  • Evaluate complaints from Cook global customer support and delivery centers to determine if they meet Regulatory Reporting requirements.
  • Use suitable complaint software systems to process complaints and investigate functions.
  • Prepare regulatory reports based on assessments.
  • Effectively communicate with regulators on regulatory reporting matters.
  • Ensure reportable events are escalated promptly to the appropriate personnel.
  • Collaborate with other Cook Companies globally for reporting purposes.
  • Respond to inquiries on AE reports from various global regulatory authorities.
  • Generate reports for Regulatory, Marketing, and Engineering requests.
  • Contribute to field action assessment through the Health Risk Assessment process.
  • Assist in coordinating Field Action activities between manufacturer and distribution centers.
  • Close out complaints as needed.
  • Contribute to Post Market Surveillance (PMS) plans and reports.
  • Maintain regulatory records to demonstrate compliance with regulations.
  • Stay informed about global medical device regulations.
  • Implement relevant regulatory requirements in accordance with specified standards.
  • Manage multiple projects and provide regular reports to regulatory management.
  • Act as a liaison on regulatory issues for Cook entities.
  • Organize regulatory records to demonstrate compliance.
  • Perform assigned duties.
  • Ensure compliance with Cook's Code of Conduct in all business matters.
  • Act as a Delegate for the Regulatory Communications Team Lead.
Qualifications
  • Department: Complaints
  • Third level Qualification in Science/Engineering preferred.
  • Experience in a regulated industry in a similar role is advantageous.
  • In-depth knowledge of EU & US medical device regulatory requirements.
  • Familiarity with regulatory requirements in MDSAP countries.
  • Desirable to have knowledge of requirements in other jurisdictions.
  • Knowledge of medical device quality standards/practices or similar industry.
  • Strong communication and problem-solving skills.
  • Proficiency in Microsoft Office and computer skills.
  • Proven organizational and self-motivational abilities.
  • Willingness to travel for company business.

About Cook Limerick

Cook Medical has been established in Limerick since 1996, initially focused on labeling and distribution and expanding over time to include manufacturing, customer support, and collaborative product development at the Innovation Centre. The Ireland site serves as the European headquarters and EMEA Support Centre, employing over 1000 people and manufacturing 10% of Cook's global product range.

Employee benefits include:

  • Hybrid Work Model
  • Company-sponsored Defined Contribution pension scheme
  • Medical Health Insurance for you and your family
  • Life Assurance and Income Protection
  • Educational Assistance
  • Performance-related Bonus
  • Comprehensive health & wellness program
  • On-site gym
  • Flexible working hours
  • Paid time off for volunteer activities
  • Free parking
  • Subsidized restaurant
  • Sports & Social club

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