REGULATORY SPECIALIST Medical Devices
- Experience Level
- Experienced (non-manager)
Regulatory Engineer for Global Medical Device Company. On behalf of my client, we are currently seeking applications. This permanent position will be responsible for, maintaining quality standards and ensuring regulatory requirements are met with regard to their products.
ESSENTIAL JOB FUNCTIONS:
Regulatory Affairs Responsibilities:
- Generate and maintain technical files for CE Marked Products and all other relevant documentation required to comply with the Medical Device Directive 93/42/EEC and its relevant national transpositions and any other national or international regulations which apply to company.
- FMEA execution and Risk management reports as per ISO 14971 as part of technical file updates.
- To correspond / communicate with auditing bodies and regulatory authorities in all relevant matters relating to company.
- To promptly reply to customer and regulatory queries in relation to quality, technical and regulatory information for products manufactured & distributed.
- To liaise with the relevant markets and update product registrations.
- Create and maintain Own Brand Labelling Files.
- The person responsible for regulatory compliance shall at least be responsible for ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
- The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
Third level qualification, degree or other formal qualification in medicine, pharmacy, engineering or another relevant scientific discipline.
A minimum of 2 years professional experience in regulatory affairs or in quality management systems relating to medical devices.
Knowledge and experience in regulatory affairs / quality compliance, quality assurance within a medical device company or Pharmaceutical field.
For full details contact Tina at +353 1 2784671 or email your CV in confidence to email@example.com