This is a newly created role reporting to the Quality Manager. My client a well- established and world leader the field of in vitro diagnostics for over 50 years, this company focuses on infectious diseases, providing automated systems and reagents for both medical analysis and product quality control in the agri-food, cosmetics and pharmaceutical industries.
- Responsible for Vigilance (adverse events reporting) reporting to the local competent authorities in a timely manner in UK and Ireland/ NEC countries as needed when Corporate notifies of an FSCA or a local reportable incident
- Responsible for reviewing and coordination of the answers to requests of information from Competent Authorities on a timely manner including the monitoring of all the requests in the company vigilance software’s and other monitoring systems. Report on issues.
- Responsible for taking PRE local decisions in case of incidents and to report these in in the company vigilance software’s.
- Communication to customers, third parties and Internal Support for other employees regarding regulatory compliance as needed.
- Accountable for reaching the reconciliation of the implemented Field Safety corrective actions in NEC and communicating regularly with the CA.
- Responsible for monitoring the regulatory environment, developing and improving the regulatory processes in the NEC
- Assist in any duty within the company as is reasonably requested
- Ideally a Bachelor of Science Degree in science or higher degree.
- Ideally 3 years of work with Regulatory Affairs, Management, Quality control, Laboratory work, Internal auditing, experience including QM project management.
- Excellent Microsoft office knowledge with documented experience
Skills and Qualifications:
- Good verbal and written communication skills in addition to analytical and organizational skills
- Attention to details and ability to understand technical and scientific documentation
- Experience in participation or arrangement of regulatory audits (i.e. ISO 9001, ISO 14001, FDA, EPA, etc.) is desired
- Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, IVDD, MDD, QSR, UL, CSA, VDE, etc.) is desirable.
NB: This is a permanent role and an immediate hire, therefore a temporary person will be considered too.
Competitive Salary + Full benefits package - list available
Contact: Michelle Singleton at AES for more details and or send your CV stating why you should be selected for this role quoting ref: MS 913701
This vacancy is being advertised by Applied Executive Selection Ltd. The services advertised by Applied Executive Selection Ltd are those of an Employment Agency.
Whilst we make every effort to reply to all applications within a week, if you have not received a reply within 14 days please assume you have been unsuccessful on this occasion.
- Medical Devices
- Quality Management
- Regulatory Affairs
- Regulatory Requirements
- audit experience
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