Medical Device Regulatory

hace 1 semana

Barcelona, Barcelona, España Jr Spain A tiempo completo
col-wide

Job Description:
About the job:Our clients refer to us as the Gold Standard in Life Sciences product quality. We are global experts in quality assurance & GxP compliance across Pharmaceutical, Biotech & Medical device manufacturing supply chains.

Rephine Barcelona is part of the Rephine Group, with offices at Spain (Barcelona), the UK (Stevenage), India and China (Shanghai).Are you a Pharmaceutical and Life Sciences lover? Are you oriented to work on a team? Are you passionate about learning? Do you want to make a difference by managing multi-Projects? Are you ready to work in Global multi-site company? We are looking for a Medical Device Regulatory & Quality Consultant to join our team.


Your main responsibilities:
Reporting to the Medical Devices Area Manager, your key responsibilities will include:

  • Participate in the definition of regulatory strategies / roadmaps to obtain marketing authorisation for medical devices (CE Mark in Europe and marketing authorization in the United States).
  • Preparation of regulatory documentation of Medical Devices (including IVDs and Medical Device Software). Create documentation of compliance with technical and regulatory requirements.
  • Quality Management System implementation (establishing procedures, work instructions and record templates) and quality process improvement.
  • Responsibility for the control, planning, execution and delivery of assigned projects. Comply with the deadlines agreed with the client.
  • Collaborate and supervise the development of documentation of the projects in which he/she is involved, following the indications of clients and Medical Devices Area manager.
  • Keep the client and Medical Devices Area manager up to date with the evolution of the project, incidents and actions of the project.
  • Strong team-work skills are required since projects are carried out by interdisciplinary teams combining company employees and customer staff. Project Management experience is an added value.

Your team:
Join our young and enthusiastic team, share our values & goals, and grow with us. You can be part of the success of our projects.

This Job is for you IF:

  • Bachelor's degree in Science, Chemical Engineering, Farmacy, Bioengineering or Biotechnology.
  • Experience working in pharmaceutical and/or medical devices environment
  • Knowledge of the European Regulation 2017/745 and 2017/746.
  • Knowledge of QMS standard ISO 13485
  • Strong teamwork skills.
  • Availability to travel. Customers are mostly located within Spain, but also at European countries, China or other.
  • Excellent communication, customer-faced skills, being able to understand customers' requirements and translate them into technical solutions, as well as being able to explain technical and regulatory concepts to non-technical audiences.
  • Fluent in both Spanish and English. Other languages are highly valuable.
  • Eager to learn and motivated.
  • Experience as auditor is highly valuable.
  • Project Management experience is highly valuable

Your career at Rephine:
We are growing and constantly evolving, looking for professionals who want to stay and develop their career with us

We offer:

Benefits:
Competitive salary according to experience, additional extra-legal vacation days, and other competitive benefits.

Teamwork:
highly qualified staff with numerous years of experience, always available to help.

Flexibility:
Hybrid mode, autonomy, reduced workday each Friday, flexible hours.

Global Company:
Growing global company and multicultural team.

Learning program:
Training and development program

  • Continuous training and English lessons
  • Occasionally teambuilding, social events and Rephiesta.
  • Excellent culture and work environment. Young and enthusiastic team of consultants.

Why Rephine?:


During the 20+ years, we have been able to work closely with many of the largest companies in Life Sciences.

We have joined their teams, worked with them at their facilities and advised them on how to improve their manufacturing quality processes.

We are growing and in constant evolution, looking for professionals who want to stay and develop with us.

Visit our career site for more information:
Careers - Rephine Applications need to be in English.#J-18808-Ljbffr

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