Acerca de Business Network
Deepull is a development-stage clinical diagnostics company focusing on direct from blood sepsis diagnostics and located in Barcelona.
POSITION SUMMARY:
This position is responsible for maintaining and ensuring that the company quality system meets FDA, UE, ISO13485, and all international market medical device requirements. The QARA specialist is also responsible for ensuring that products and their labelling meet all regulatory requirements (national and international).
The successful candidate must be located in Barcelona and possess a broad array of diverse technical and scientific skills and subject matter knowledge, the ability to quickly identify and adjust to changing priorities.
The QARA Specialist reports directly to the QARA Manager.
ESSENTIAL FUNCTIONS OF THE POSITION:
· Manage the Documentation Control Process. Inspect, verify and maintain compliance documentation
· Assist with development and maintenance IVD Technical File.
· Support for certification of ISO 13485.
· Foster a close working relationship with key stakeholders, including the Quality System, Supply Chain, Sales and Marketing and Design & Development teams as well as other senior management in the business, including keeping abreast of key business, regulatory and industry developments and any changes to procedures and practices.
· Establish compliance with FDA, including company registration, product submissions, establishing FDA communication/channels for compliance on medical device listings/classifications.
· Preparation, drafting, review and submission of applications for new registrations to national and international health authorities and monitoring of the evolution of registrations once submitted.
· Evaluation of internal and/or external tasks to optimise the timing of the different phases of registration
· Establish compliance with the EU market IVDR, including EC Mark applications via technical files.
· Conduct internal audits and run external ISO audit schedules, correspondence and closing of findings.
· Keep up to date with current medical device guidelines, legislation, and publications, assessing the impact of changes to the organisation.
· Risk Management Team Member.
· Contribute to the provision of education and training on relevant compliance activities particularly relating to all QMS requirements for all departments
DESIRED SKILLS FOR THIS POSITION:
3-6 years experience working with medical device/IVD in the Quality and Regulatory field.
Scheduling and performing internal and vendor audits.
Writing standard operating procedures and work instructions.
Relevant, combined research, internship, and professional experience in a GXP-regulated medical device, pharmaceutical or environmental laboratory environment.
In-depth knowledge of the regulatory context (IVDR and FDA). Familiarity with 21CFR820, ISO 13485, ISO 14971, ISO 9001 series of standards and related national and international medical device industry standards and regulations.
High level of English
ADDITIONAL SKILLS FOR THIS POSITION:
Experience planning, scheduling, executing, and completing project tasks to meet deadlines
Ability to work under fast-paced conditions, prioritize duties and multitask as needed
Ability to make decisions and use good situational judgment skills
Ability to communicate with colleagues across all levels of the organization and work in cross-functional teams
Detail-oriented, with strong commitment to accuracy and completeness of work
Excellent writing and verbal skills
Intermediate Microsoft Office skills (Excel, Word, PowerPoint)
DESIRED QUALIFICATIONS:
A Bachelor of Science Degree with 3-6 years’ experience in Quality Assurance and Regulatory Affairs for Medical Devices.
