QA/RA Manager / Regulatory Affairs Specialist / Quality Assurance

Om Bravura:

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Om kunden:

About the company

Triomed AB is a medical technology company in Lund that develops systems for patients with kidney and heart failure. The systems are based on proprietary technologies and will improve the quality of life for kidney and heart disease around the world.
Triomed, which today has 13 employees now wants to strengthen its organization with a hands-on and pragmatic Quality and Regulatory Manager.

Arbetsuppgifter:

Work Tasks:
As the QA/RA Manager your main responsibility is the task of developing, documenting, implementing and maintaining necessary processes and procedures to ensure that the specified product quality will be achieved. You are responsible for Triomed’ s Quality Management System and need to make sure Triomed is compliant with the laws, regulations and standards for medical devices in various markets. You work in close collaboration with external specialists, specializing in EU and US regulations where you head the work for multiple registration processes.

Responsibilities
• Responsible for the registration process of Triomed’ s products in all applicable markets
• Develop Triomed’s regulatory strategy in conjunction with external advisers and key stakeholders
• Develop and implement quality management strategies and plans
• Monitor risk management process performance and take necessary action ensure adherence to risk management plan and promote awareness of product liability and design-quality issues across the organization

Profil:

Education, Experience, Personal Characteristics, and other Requirements:
• BSc or MSc level in science or engineering
• Several years’ experience in the field of quality and regulatory within medical devices
• Strong Knowledge of Quality System Regulation (QSR) - 21 CFR Part 820, ISO 13485 and EU Medical Device Regulation
• Experience of Risk management and risk analysis – ISO 14971
• Hands on experience of applicable ISO standards for the products
• Experience of leading registration processes for the EU and/or US markets
• Excellent verbal and written communication and presentation skills in English

We expect you to be good team player that enjoys working within cross functional teams with people of different cultures and experiences. You have no problem working independently and have excellent problem solving, communication and analytical skills. You are comfortable writing documents yourself and instructing others how to do it. You like to take responsibility, are open-minded and can quickly shift your focus when priorities change.

Övrig information:

Other information:
Start: As agreed upon
Placement: Lund
Salary: According to agreement

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Har du frågor om tjänsten eller kring din registrering är du välkommen att kontakta vår kandidatsupport på vår chatt, info@bravura.se eller 08-400 240 50 så hjälper vi dig. Ange vilken tjänst det gäller.

Vi rekommenderar att du skickar in din ansökan omgående då vi gör ett löpande urval. Välkommen med din ansökan!

Sökord: QA, RA, Manager, MedTech, QMS, FDA, QSR, ISO, Medical Device, Pharmaceutical, QA/RA, Science, Engineering, Lund, Medicinteknik