Ref. no.: JO-1106-232603
Job description: Post Market Surveillance Analyst (RA)
In partnership with its client, Kenny-Whelan is currently seeking a Post Market Surveillance Analyst (RA) to work for their client in the Midlands area. The PMS Analyst is responsible for ensuring that the client meets its statutory Regulatory obligations under the Medical Device Vigilance requirements of the Medical Device Directive (MDD) within the EEA, and comparable reporting responsibilities in other countries in EMEA.
Job Responsibilities:
Complete and file Initial and Final Device Vigilance Reports, for all Incidents deemed reportable by designated personnel at the Global Business Units, in accordance with reporting timeframes.
Liaise with GBUs and in-country RA personnel, where the relevant Competent Authority (CA) requires additional information and/or clarifications.
Provide supplementary information to the Competent Authorities, and follow-up with GBUs in a timely manner, in order to ensure that CAs’ timelines are met, wherever possible.
Maintain familiarity with MDD and any associated Directives, MEDDEVs, and national legislation, ensuring compliance with updated regulations, wherever applicable, in accordance with regional and corporate procedures.
Review decision-trees and other supporting information from the Complaint Tracking System, in order to understand rationale /decision on whether incidents are reportable. Query rationale where necessary and advise RA Manager EMEA wherever the analyst believes that the rationale for the decision may not be discernible to the CA without further enquiry.
Assist with communication with Competent Authority, and work with in-country RA personnel, where directed by RA Manager EMEA, in coordinating follow-up meetings or contact with the CA, per a clearly defined agenda.
Cultivate an expertise in both CTS system, and PMS Regulations, in order to advise in-country staff on specific points, and provide training where requested by RA management.
Provide summary reports to senior management or other groups as required. Review and analyse trends from data generated, or data supplied by GBUs, and summarise appropriately.
Receive updates and regulatory information from CAs and other relevant agencies, and communicate with colleagues and management where this information is relevant to PMS and reporting activities.
Collaborate with RA colleagues and other functions (e.g. Sales, Technical Services, QA etc) on Field Safety Corrective Actions (FSCAs) as required. Maintain familiarity with MEDDEVs and Internal Procedures on FSCAs, assisting with communications with CAs as required.
Complete project assignments, related to the above activities and other personal development projects, as agreed with, or assigned by, RA management.
Skills, Abilities and Education:
• Applicants should ideally have 2/3 years experience of working within a highly regulated environment (preferably healthcare), and have experience in communicating with government or statutory authorities.
• Applicants should have the ability to generate and review reports on regulatory matters in a timely manner, and be accountable for the accuracy and integrity of information provided as input for decision-making.
• Applicants should ideally have a working knowledge of fundamental healthcare-related processes, and be able to review detailed responses to Competent Authorities – including Instructions For Use (IFUs), dimensional analyses, reports, complaint-data etc. – for completeness, relevance and accuracy.
• Leaving Certificate or equivalent is essential. A third-level or vocational qualification in a relevant area would be an advantage. Further training will be provided.
Job Requirements:
• Good IT and Keyboard Skills and ability to work with MS Word, MS Access and MS Excel, along with Corporate Complaint-tracking and Documentation Systems.
• Excellent organizational skills, with meticulous approach to filing and storage of documentation, and ability to follow-up in ensuring that status reports, procedures, and other relevant documents, are kept fully up-to-date.
• Excellent verbal and written communication skills, allowing clear and precise communication on urgent compliance and device-vigilance issues in accordance with procedure, including all relevant information.
• Flexible approach, and willingness to work unsociable hours occasionally, when completing reporting or follow-up duties.
• Assertiveness and persistence in requesting information and following-up on urgent issues.
• Discretion and sensitivity when processing confidential information on patient-outcomes or institutions.
• The ability to interact with employees at all levels of the organisation and work as part of a team.
• NOTE: Occasional Travel may be required as part of this role.
Kenny-Whelan Contact:
If you are interested in the above role, please send an updated CV marked for the attention of Linda Nugent, email: lnugent@kenny-whelan.ie or telephone for a confidential chat on 021-4665407
