We are looking for:
Regulatory Affairs & Quality Assurance Assistant
competitive benefits | Serbia
As a Regulatory Affairs & Quality Assurance Assistant EE Distributor Market at Covidien, you can be sure of great training and development opportunities in a stable, rapidly growing company, an excellent benefits package, and attractive employment conditions.
You will provide Regulatory support to Covidien operations in Balkan countries (Serbia, Bosnia & Hercegovina, Croatia, Montenegro, Macedonia). You will ensure that all medical devices commercialised by Covidien in the Balkan countries markets meet all commercial and regulatory requirements by preparing, verifying and submitting product notifications files for medical devices.You'll represent the Company in all its dealings with distributors, authorities and hospitals.
- To ensure that all information received from post market surveillance activities e.g. complaints, are entered into the relevant business units systems for processing
- Monitoring Medical Devices Vigilance procedures according to National Laws and Rules
- To ensure that all relevant procedures related to regulatory and quality activities are communicated to relevant local staff and respective distributors
- Provide relevant certificates and declarations of conformity of the commercialized medical devices as requested
- Liaise with manufacturing facilities, if required, to obtain technical information that may be required to support commercial or regulatory requirements
- Archiving and follow-up of quality complaints, incidents or adverse events from customers
- Approval of promotional and advertising material regarding commercialised medical devices
Skills & Qualifications
- University degree in pharmacy - preferred, medical science, biology, chemistry or related field
- At least one year of experience with regulatory ideally from the medical devices company
- Knowledge of medical devices and pharmaceutical legislation in the Balkan countries would be a plus
- A well-developed knowledge of MS Office suite
- English language skills to business standard
- Excellent interpersonal skills
- Attention to detail
- Effective prioritisation and time management skills
To apply please send your CV in English.
Deadline for applications: 23.06.2012.