Post Market Surveillance Specialist 1
Cook Medical
- Limerick
- Temporary
- Full-time
- Department Complaints
- Assess complaints from Cook global customer support and delivery centres for adequate information to determine if event meets Regulatory Reporting requirements.
- Utilize appropriate complaint software systems for processing complaints to/from customer support and delivery centres and QE Investigation functions.
- Generate appropriate regulatory reports based on assessment.
- Liaise effectively with regulators on all issues with regard to regulatory reporting.
- Ensuring that confirmed reportable events are escalated to the appropriate personnel in a timely manner.
- Communicate with other Cook Companies globally as necessary for reporting.
- Generate responses to inquiries on AE reports from various global regulatory authorities.
- Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests.
- Input into the assessment of field action through the Health Risk Assessment process.
- Assist in coordination of Field Action administration activities between manufacturer and distribution centre.
- Close out of complaints as necessary.
- Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports. Maintains appropriate regulatory records to demonstrate compliance with applicable regulations.
- Maintain an excellent understanding of global medical device regulations.
- Responsibility for implementing applicable regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required.
- Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
- Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
- Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
- Performs additional duties as assigned.
- Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
- Delegate for the Regulatory Communications Team Lead.
- Department Complaints
- Third level Qualification in Science/Engineering desired.
- Experience in a regulated industry in a similar role is beneficial.
- Thorough knowledge of the EU & US medical device regulatory requirements.
- Knowledge of regulatory requirements in MDSAP countries.
- Desirable to have knowledge of requirements in other jurisdictions.
- Knowledge of medical device quality standards/practises or similar regulated industry.
- Good communication and inter-personal skills.
- Proven problem-solving skills.
- Good computer skills including knowledge of Microsoft ® Office.
- Proven organisational skills.
- High self-motivation.
- Willingness and availability to travel on company business.
- Hybrid Work Model
- Company sponsored Defined Contribution pension scheme
- Medical Health Insurance cover for you and your immediate family
- Life Assurance and Income Protection cover
- Educational Assistance
- Performance related Bonus
- Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks
- Fully equipped gym on site
- 39-hour week with flexible start & finish times
- Paid time off to participate in volunteer activities
- Free parking
- Subsidised restaurant
- Sports & Social club