Medical Device Technical Manager

The responsibilities of the Technical Manager are as follows:

• Supervise the company’s activities in relation to the medical device.
• Check that the medical devices manufactured, imported, grouped and/or sterilized comply with the applicable regulatory requirements.
• Guarantee the suitability of the technical file, as well as any other document required by regulation, in accordance with the company’s activity in relation to the medical device (manufacture, grouping, import or sterilisation.
• Review, direct and manage possible incidents involving the medical device, in accordance with the surveillance system.
• Supervision, registration and adaptation of the implementation cards to those products that are applicable to them.
• Collaborate, and act as their interlocutor, with the health authorities in cases where appropriate.
• Provide the health authorities with documentation demonstrating the conformity of the product whenever required by them.
• Preparation, management and supervision of marketing or marketing communications of the products to which it is applicable.
• Preparation and supervision of the documentation required in the register of those responsible for placing on the market the placing on the market of the products that are applicable.
• Coordination and presentation of the authorisation of trials or clinical research.
• Control and authorisation of advertising and marketing content related to the product, always within the law.
• For manufacturing companies, compliance with regulatory requirements and the performance and documentation of the tests that are applicable to the company’s medical device .
• For grouping companies, ensure that all the products that make up the grouping have CE marking. Ensure that all products will be used in accordance with the intended purpose specified by their respective manufacturer. Guarantee that the product resulting from the grouping, through its documentation, includes the information provided by each of the respective manufacturers. That prior to its placing on the market, the legislative obligations regarding the communication of placing on the market have been complied with.
• In the case of sterilizing companies, that the procedures have been validated, with positive results, that before releasing each batch or product, the requirements applied are in accordance with the applicable requirements.
• In the case of importing companies, that the product has the declarations, certifications and any document that is required in relation to its nature. The edition of the required documentation, in accordance with the applicable needs. Certify that all warnings, advice and recommendations applicable to the country where the product is to be distributed have been included.