The PMS Analyst is responsible for ensuring that our 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.
This is an initial six month contract role based in the Midlands with an excellent chance of a contract extension and I can provide more information on request.
Responsibilities of a Regulatory Affairs Officer - Post Market Surveillance
- Complete and file Initial and Final Device Vigilance Reports, for all Incidents deemed reportable by designated personnel at the Global Business Units (GBUs), 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 in 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.
- 3rd level vocational qualification in a relevant area would be an advantage. Further training will be provided.
- Should have 2/3 years? experience of working within a highly regulated environment (preferably healthcare) with experience in communicating with government or statutory authorities.
- 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.
- The PMS Analyst 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.
- 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.
Follow us on Twitter, Facebook and LinkedIn
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.