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Benjamin KNEIP

Rungis cedex

En résumé

Enthusiastic and highly motivated regulatory affairs associate looking for an exciting new role within the healthcare industry.
After a year and a half living in Australia, learning from a different culture and improving my communication skills, I am eager to challenge myself in the role that I want to devote my career for, regulatory affairs associate.
Here is what I have to offer to your team:
- Immediate availability.
- Master's degree in Healthcare products.
- 1,5 years working experience registering medical devices in Europe, Asia, Middle East and Latin America.
- Key strengths of an efficient RAA: rigorous, autonomous, team worker, respect of deadlines, multitasking.
Can be contacted any time at benjamin.kneip@gmail.com or directly on +336 8030 7090.

Mes compétences :
Medical Devices
Regulatory Submissions
Regulatory Affairs

Entreprises

  • Biotronik - Regulatory affairs associate

    Rungis cedex 2015 - maintenant

  • In a Rush - Mascot Corner Café - Store manager / Waiter / Cashier

    2013 - 2015 - Managing 4 people in an efficient and positive way.
    - Organising orders to the suppliers, closing the registers, responding to customer enquiries.
    - Welcoming customers, suggesting food and beverages and taking orders.
    - Working co-operatively with member of the staff sharing responsibilities and remaining initiative on given tasks.

  • Stago - Regulatory affairs associate

    Asnières-sur-Seine 2013 - 2013 Diagnostica STAGO is a worldwide reference company specialised in the field of Haemostasis and thrombosis providing test reagents and their associated analysers in over 110 countries.

    Within the Quality Assurance - Regulatory Affairs department:
    - Registered In Vitro Diagnostic medical devices (reagents to help the diagnostic of blood disorders and their associated analysers) worldwide including in Mexico, Argentina, Singapore, South Korea, India, Ukraine.
    - Prepared and participated to meetings and call conferences with local distributors & registration holders.
    - Contributed to the worldwide regulatory monitoring.
    - Responded to requests from different STAGO’s departments such as marketing, supply chain, quality assurance.

    Technical background: CE mark technical file, European Directive 98/79/EEC, Worldwide registration files, Haemostasis

  • Sorin - Regulatory affairs associate

    Paris 2012 - 2013 SORIN Cardiac Rhythm Management BU is a global company and European leader which develops, manufactures and markets medical technologies for cardiac surgery and the treatment of cardiac rhythm disorders.

    Within the Regulatory Affairs department:
    - Initiated and ensured the registration of Active Implantable Medical Devices (pacemakers, defibrillators and their associated leads) in Ukraine, Cuba and Egypt.
    - Worldwide regulatory affairs monitoring.
    - Support the regulatory affairs team members for different submissions.

    Technical background: CE mark technical file, European directive 90/385/EEC, Worldwide registration files, Cardiology.

  • PROTHIA - Internship in Quality Assurance - Regulatory Affairs

    2012 - 2012 Prothia is a small company (10-15 employees) designing, manufacturing, marketing and distributing medical devices served cardiology, perinatalogy and rehabilitation.

    Working with the QA-RA manager and the biomedical engineer:
    - Discovered and prepared CE mark files for Class IIa and Class IIb medical devices (in perinatalogy).
    - Edited Quality Assurance procedures.
    - Update of a lead's technical file for compliance with the IEC 60601-1-2 standard.

    Technical background: CE mark technical file, European directive 2007/47/EEC, ISO 13485, IEC 60601-1-2, perinatalogy, cardiology.

  • Inserm - Internship followed by a junior engineer position.

    PARIS 13 2011 - 2011 The UMR 913 is a French leader in the study of the digestive and nervous system involvement in chronic digestive diseases (Ulcerative colitis, Crohn's disease, irritable bowel syndrome) and extra-intestinal (Obesity, Parkinson).

    Characterization of transcription factors involved in the postnatal maturation of the enteric nervous system.
    Study carried out using molecular biology (cloning, qPCR), immunology (immunostaining) and cell culture (co-cultures) techniques.

Formations

  • Université Nantes

    Nantes 2007 - 2012 Master 2 Control and development of healthcare products

    With honors.
    Courses: Medical Device (CE mark file, European Directive 93/42/EEC, Materiovigilance), Quality Assurance, Control and Development of Healthcare Products, Human Physiology, Genetic Engineering, Marketing.

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