Quality and Regulatory Affairs Manager

Full Time
  • Full Time
  • Coimbra
  • 2020-05-11 2020-06-10
  • Gestão / Administração / Secretariado
  • Licenciatura
Avatar Perceive3D
Ver Empresa
597708

Perceive3D:

Perceive3D (P3D) is a start-up company located in Coimbra, Portugal, that specializes in computer

vision technology to create a disruptive navigation system for orthopedics surgery using

Augmented Reality that leverages surgeon performance and improves clinical outcome. The

company is certified according ISO 13485 and works in close connection with the major players in

the orthopedics market that integrate P3D’s solutions into their product lines for global

commercialization. P3D actively invests in its work force and the successful candidate will be

entitled to receive training and support from specialized consultants in order to excel in performing

the assigned duties.

Role Summary/Purpose:

The company is looking for a Quality and Regulatory Affairs Manager to integrate the team in

Coimbra. The successful candidate will be responsible for the maintenance of the quality

management system and the implementation of the defined regulatory strategy for the submission

of P3D products to FDA and MDD/MDR.

Desired Profile:

Knowledge and experience with one or more of the following:
Quality management systems and standards (ISO 9001, ISO 13485, IEC 62304, ISO 14971)
Regulation and certification in medical device industry (CE marking, FDA)
Complex clerical and administrative tasks (procurement and purchasing, elaboration of reports and technical documents, organization of events)

External suppliers procurement and audits.
Professional experience of +3 years in quality management and/or regulatory affairs;
Fluency in English (written and spoken);
Ability to simultaneously manage multiple complex tasks and priorities;
Autonomy and capability of taking responsibility for the timely execution of projects and tasks;
Good communication skills and interpersonal relations.

Duties and Responsibilities:

The successful candidate will directly report to P3D Administration about the following duties:

Maintenance of the Quality Management System for Medical Devices according to ISO
13485
Ensure compliance with all relevant national and international standards and legislation;
Ensure that all Standard Operating Procedures (SOPs) of the company are executed

accordingly;

Participate in the treatment of non-conformities and complaints;
Plan and conduct internal and external audits;
Support the creation of quality related technical documentation according to IEC 62304;
Perform risk management according to ISO 14971/FMEA technique;
Establish and follow regulatory startegy for the certification of medical devices for FDA and CE

approval. Work closely with company’s consultants for regulatory affairs and prepare technical

folder for submission.

Compensation and benefits: The compensation will depend on candidate experience and will be

complemented by other benefits such as health insurance or the possibility of formal training and

education in relevant areas to properly perform the role.

Location: Coimbra, Portugal.

Contact: Please send a CV along with a short motivation letter. The application should be sent by email with “Quality and Regulatory Affairs Manager position” in the subject.

Você tem que entrar na sua conta para poder candidatar-se a esta oferta.