Clinical Quality Assurance Manager - Barcelona, España - Neuroelectrics

Neuroelectrics

Empresa verificada

Barcelona, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

Who we are:

Neuroelectrics is a creative, high-tech company offering the best-in-class non-invasive and high-definition electrical brain stimulation technology for personalized neuromodulation.

By measuring and modifying brain function, we aim to restore brain health, minimize disabilities and create a better life for patients.

We are looking for new members of our team who already live by our shared values and are inspired by our company's

Vision. Accelerate the evolution of brain science and technology by delivering advanced solutions to help end patients suffering from brain pathologies; and our

Mission. Revolutionize the understanding of the brain through new personalized neuromodulation therapies, anywhere and at any time.

Position Summary:

What will you do:

Review of clinical documents and regulatory submissions such as protocols, ICF, IBs, IFU, Clinical Study Reports, Clinical Evaluation Plan & Report, and other studyrelated documents according to Neuroelectrics

QMS, ICH

GCPs, EU, FDA, and local requirements.
Work with all relevant internal stakeholders, including Clinical Operations, Medical Writing/Monitoring, Regulatory Affairs, Supplies, etc., to drive the clinical investigation development needs.
Assist in drafting, reviewing, and revising Standard Operating Procedures, Work Instructions, Forms, and Templates.
Work on the development of investigations CAPA plans with both internal and external stakeholders.
Assist with providing internal training sessions as needed.
As indicated by audit observations, new regulations, guidance documents, and industry standards recommend and implement process improvements to internal programs.
Guide on quality compliance issues and process improvements.
Responsible for vendor ́s (CRO)qualifications
Provide Clinical Audit Plans for each of the clinical studies.
Review audit documentation such as audit reports, responses, Corrective and Preventative Actions (CAPAs), etc.
Work on and /or oversee the external audit program and liaise with contract auditors for both clinical site audits and CRO/Vendor audits.

What do you need:

Must-have

Bachelor's Degree in healthcare related field preferred or an equivalent combination of education and experience
4 years of GCP experience working in a pharmaceutical, biotechnology, or medical devices firm or with a CRO for clinical investigations: pilot, pivotal, and PMCF.
Knowledge and understanding of medical device development and the clinical investigation process.
Knowledge of FDA and EU Regulations and Guidance, as well as global Regulatory Standards and associated ICH Guidelines.
Proven track record of building relationships with both internal & external stakeholders.
Proficiency in English at both oral and written levels

Bonus points

Experience supporting regulatory authority inspections
Quality Assurance Audit certification
Fluency in Spanish

You will be the perfect fit if you are/have:

Passionate about making a difference, gifted with a can-do attitude.
Reliable, Responsible, and Respectful.
Good communication and presentation skills.
Ability to adapt and work effectively within a rapidly changing and growing environment.
Entrepreneurial spirit with the hunger to succeed; act with a founder's mindset: have urgency, grit, be adaptable to change, and push boundaries.
Team player, collaborative, innovative, get things done mind.
Show initiative in setting and meeting goals within an environment of managed change.
Ability to work under pressure, responsible for multiple vital tasks in parallel
Commitment to quality.

If you join us, you will enjoy:

Competitive salary in the sector (according to your experience/skills).
26 vacation days per year + 24th and 31th of December
Fully stocked kitchen (Coffee, organic fruits, snacks, and beverages).
Flexible Working Hours
Hybrid work.
Private Health insurance, including dental coverage.
Professional development and collaborative environment.
Unique opportunity to join our company early with excellent market traction and huge potential to grow
Incredible office in Barcelona in Av. Tibidabo. (shower, stunning views of all of Barcelona, etc.)
Team Building Events.
Much more still to come.

About us:

Neuroelectrics is a creative, high-tech company offering the best-in-class non-invasive and high-definition electrical brain stimulation technology for personalized neuromodulation.

By measuring and modifying brain function, we aim to restore brain health, minimize disabilities and create a better life for patients.