Manager Regulatory Affairs Operations

hace 2 meses

Spain HARTMANN GROUP Teletrabajo Freelance A tiempo completo
Join our team as a

Manager Regulatory Affairs Operations - Temporary for 12 months -

Mataró

Are you ready to go further?

Reliable. Competent. Thanks to mutual cooperation, we ensure that a healthy optimum is always attained, both professionally and personally. These qualities have turned the HARTMANN GROUP into one of the leading international providers of medical and hygiene products. The secret of our success? Scope for development. We offer our just over 11,000 employees in more than 30 countries the opportunity of participating in shaping our common future. Take advantage of your new scope of action in the Regulatory Affairs Area at LABORATORIOS HARTMANN S.A.

Manager Regulatory Affairs Operations - Temporary for 12 months -

Responsibilities

Your area of responsibility in the Regulatory Affairs Area:
Act as RAO Business Partner and work closely with Development and Marketing to manage development projects and changes from an RA perspective.Coordinate internal RA functions and provide project support.Global monitoring and improvement of regulatory product documentation, conformity assessment and resulting declaration of conformity based on global regulatory compliance.Support strategic and conceptual development of the Regulatory Affairs Operations department.Support BD`s by providing strategic input and guidance on regulatory issues.Strategic planning, conceptual development and delivery of training and mentoring on regulatory issues and needs related to the defined area of responsibility of global regulatory product documentation and compliance assessment.
What We Look For
Bachelor’s or Master’s degree in natural or technical sciences, or equivalent education.Experience in active and non-active medical devices, Technical Documentation, regulatory product documentation and conformity assessments.In-depth understanding of global regulatory requirements for medical devices.Ideally knowledge of European and German regulatory requirements for personal protective equipment, pharmaceuticals, biocidal products and chemicals.Knowledge of business processes and global quality management systems in the medical device industry, such as ISO 13485.Interest to work in an international team.Very good knowledge of English and Spanish written spoken. Basic knowledge of German would be preferable.
Are you ready for an internationally successful company? Do you appreciate the benefits of an outstanding market position? Then start your career at HARTMANN now. With us, attractive framework conditions and excellent training opportunities await you. After all, our greatest potential is your personal development.

Departament: Regulatory Affairs

If you are interested in the position, please it is necessarythat you previously apply to the offer and send us your CV through the option “Apply Now” that appears below.

Once you sign up, if you have any questions about the requested profile, please contact Sandra Martin.

Email: sandra.martin@hartmann.info

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