JD-004 Quality Manager and 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 included	20221219	3
Regulatory requirements awareness responsibility included	20221227	4

Education

University degree: Bachelor's degree in engineering, science or equivalent.

Experience

>=5 years

Skills

• Knowledge of medical devices regulatory compliance.
• Knowledge of iso 9001 and/or iso 13485.
• Advanced spoken and written english (C1 level).
• Organised, tenacious, goal and quality oriented, frustration tolerance and decision making skills.

Responsibilities

Quality Manager responsibilities

• To manage the quality system and its documents.
• To ensure and supervise the effectiveness of the quality system and its maintenance.
• To edit, review and maintain the documents according to GP-001 Documents and records control.
• To coordinate the actions required to obtain, even actively, the information from the post-market experience.
• To inform the JD-005and the JD-001 of all the information related to the post-market experience.
• Top responsible for the performance and effectiveness of the feedback process.
• To compile, analyse and evaluate the complaints and claims.
• To compile, analyse and evaluate the non-conformities.
• To identify, keep records, segregate and manage non-conforming product and control non-conformities and their corrective and preventive actions.
• To record product development data.
• To collect records to guarantee the traceability of the products developed.
• To notify and design the internal audit programme.
• To manage the records of internal and external audits.
• To monitor the actions implemented as a result of the audits.
• To develop the training plan, register the training report and maintain the associated records.
• To notify the JD-005and the JD-001 of any non-conformity, deviation, need or abnormality.

Person Responsible for Regulatory Compliance (PRRC)

• 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 edit, review and maintain the documents according to GP-001 Documents and records control.
• To identify and communicate to interested parties the medical device requirements.
• To elaborate, together with the JD-005, the annual product report.
• 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 verify the risk management report and records.
• 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 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 carry out the correct monitoring of the medical device during its entire life cycle.
• To request training to the General Manager and attend said training.
• To prepare and supervise the required documentation in the registry of the responsible for placing the products on the market.
• To control and authorise the advertising and marketing content related to the product, always within the law.
• 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.
• Before releasing a product, to check its conformity properly through the quality management system used by the company.
• To guarantee the existence and up-to-date status of the technical documentation and the EU declaration of product conformity.
• To ensure that post-marketing monitoring obligations are met in accordance with article 10, paragraph 10 of the MDR 2017/745.
• 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.
• To promote the awareness of regulatory and other requirements through the organisation

Approved by	Accepted by
E-Signature (Appfire integration): Andy Aguilar 5DD4F1FFA216A372F99E6A601D0A1A68 Signer name: Andy Aguilar Signing time: Tue, 27 Dec 2022 09:09:16 GMT Reason: Approved	E-Signature (Appfire integration): María Diez AAF2F90C1D69EFD25BE4A5F8F43D5001 Signer name: María Diez Signing time: Tue, 27 Dec 2022 09:20:56 GMT Reason: Accepted
JD-001 General Manager	JD-004 Quality Manager and Person Responsible for Regulatory Compliance (PRRC)