Clinical Quality Assurance Manager

hace 1 mes

Barcelona, España Neuroelectrics A tiempo completo

**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 study-related 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.

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