MEDICAL DEVICE REGULATORY & QUALITY CONSULTANT

Join Rephine Barcelona: Leading Life Sciences Quality WorldwideAt Rephine, we set the standard for quality assurance and GxP compliance in the Life Sciences industry. With offices in Barcelona, the UK, and China, we support the Pharmaceutical, Biotech, and Medical Device supply chains globally.Who We're Looking For:Are you passionate about regulatory affairs and quality management in the Pharma and Life Sciences sector? Do you thrive in dynamic environments, eager to take on multiple projects and drive real impact? If you're excited by the challenge of enhancing compliance for medical devices, we want you as our next Regulatory Affairs Consultant in Barcelona.Your Role:In this consultant role, you'll lead projects focused on several key areas:Regulatory Strategy Development: Collaborate in defining regulatory strategies and roadmaps to obtain marketing authorization for medical devices, including CE Mark in Europe and FDA approval in the United States.Documentation Preparation: Prepare comprehensive regulatory documentation for medical devices, including IVDs and medical device software, ensuring compliance with technical and regulatory requirements.Quality Management System Implementation: Lead the establishment of Quality Management Systems (QMS), including procedures, work instructions, and templates, while continuously improving quality processes.Project Management: Oversee the planning, execution, and delivery of assigned projects, ensuring compliance with deadlines agreed upon with clients.Client Collaboration: Work closely with clients and the Medical Devices Area Manager, supervising project documentation and keeping stakeholders informed of project developments.Team Collaboration: Utilize strong teamwork skills to work effectively within interdisciplinary teams, ensuring successful project outcomes.What You Bring:A Bachelor’s degree in Science, Chemical Engineering, Pharmacy, Bioengineering, or Biotechnology.Experience in the pharmaceutical and/or medical device industry, with knowledge of European Regulations 2017/745 and 2017/746.Familiarity with QMS standards, particularly ISO 13485.Strong teamwork and communication skills, with the ability to understand customer requirements and translate them into technical solutions.Fluency in Spanish and English; proficiency in additional languages is a plus.Willingness to travel as needed, primarily within Spain and occasionally to other European countries and China.A proactive attitude with a strong desire to learn and grow.Experience in project management and auditing is highly valuable.Why Choose Rephine?We believe in rewarding talent and commitment with a comprehensive benefits package designed to support your personal and professional growth:Competitive Compensation: A salary that reflects your experience, along with additional vacation days and other benefits.Work-Life Balance: Take advantage of our hybrid work model, flexible hours, and a shorter workday on Fridays, allowing you to maintain a healthy balance between work and personal life.Global Exposure: Work with a multicultural team across multiple countries, providing opportunities to expand your professional network and gain international experience.Dynamic Work Environment: Join a young, enthusiastic team where your contributions are valued, and your ideas can shape the future of the company.Flexible Salary Options: Benefit from salary sacrifice schemes and more flexibility in managing your compensation package.Opportunities for Growth: We provide a nurturing environment where your career can grow beyond expectations. Whether you're looking for new challenges or leadership opportunities, Rephine is committed to your continuous development.For over 20 years, Rephine has been at the forefront of improving manufacturing quality processes for leading Life Sciences companies. We’re evolving rapidly and looking for passionate professionals eager to grow with us.Ready to embark on this journey?Visit our career site to learn more and apply in English.