JD-005 Technical Manager & Person Responsible for Regulatory Compliance (PRRC) 2022_001
Version control
| Reason for review | Date | Version id |
|---|---|---|
| First version | 20201124 | 1 |
| Styling and literary improvements | 20220911 | 2 |
| PRRC responsibilities updated | 20221219 | 3 |
Education
Bachelor's degree in engineering or equivalent.
Experience
>=1 years
Skills
- Training in medical device legal requirements.
- Knowledge of iso 9001 and/or iso 13485.
- Advanced spoken and written english.
- Analytical capacity and decision making results and quality oriented planification and organization.
Responsibilities
- Responsible for the regulatory compliance of the medical device developed, manufactured and/or marketed by the company.
- To supervise the activities of the company in relation to the medical device.
- To comply with all applicable essential requirements
- To edit, review and maintain the medical devices technical file according to
GP-001 Documents and records control. - To identify and communicate to interested parties the medical device requirements.
- Representative of top management.
- To elaborate the annual product report.
- To detect any incident related to the product, its safety and operation.
- To make the pertinent communications to the health authorities responsible in each case in the presence of serious incidents and/or modifications of the technical documentation, product, general safety and performance requirements and their intended purpose.
- To collaborate, and act as interlocutor with the health authorities where appropriate.
- To provide the health authorities with the documentation that demonstrates the conformity of the product whenever it is required by them.
- To directly supervise all the development and outsourced activities.
- To release the finished product for its subsequent commercialization.
- To verify the risk management report and records.
- To manage the design, redesign and development compliance process of the medical device manufactured or developed by the company.
- To analyse the non-conformities that may represent a serious incident related to the safety and operation of the product.
- To control and analyse product trends.
- To collect, or to make someone collect, all the post-marketing monitoring information.
- To collect and document, or to make someone collect and document, the preclinical and clinical product information.
- To identify the status of the company's medical devices, as well as the correct assignment of the batch number, licence or unique identification of the medical device.
- To supervise the advertising messages, communications and publicity of the company in relation to the medical device, always within the law.
- To carry out, or to make someone carry out, the correct monitoring of the medical device during its entire life cycle.
- To notify the Quality Manager of any non-conformity, deviation, need or abnormality.
- To request training to the Quality Manager and attend said training.
- To notify the existence of non-conforming products or materials to the Quality Manager for their correct identification, documentation, segregation, evaluation and control.
- To prepare, manage and supervise the marketing communications or placing on the market of the products to which it is applicable.
- To prepare and supervise the required documentation in the registry of the responsible for placing the products on the market.
- To coordinate and present the authorization of clinical trials or investigations where appropriate.
- To guarantee the general safety and performance requirements compliance and the performance and documentation of the tests that are applicable to the company's medical device.
- To execute and coordinate the obligations imposed by the customer's quality system to the Quality Manager.
- Before releasing a product, to make someone check its conformity properly through the quality management system used by the company.
- To guarantee that, in the case of products under investigation, the declaration referred to in section 4.1 of chapter II of annex XV of MDR 745/2017 has been made.
- Vigilance system responsible for the quality system.
| Approved by | Accepted by |
|---|---|
E-Signature (Appfire integration):  Andy Aguilar 08CD71C6B0088020F0B19EB8265A9897 Signer name: Andy Aguilar Signing time: Mon, 19 Dec 2022 09:35:32 GMT Reason: Approved | E-Signature (Appfire integration): Alfonso Medela 0503F40462538C39807985F8963EE07A Signer name: Alfonso Medela Signing time: Tue, 20 Dec 2022 13:22:33 GMT Reason: Accepted |
| JD-001 General Manager | JD-005 Technical Manager & Person Responsible for Regulatory Compliance (PRRC) |