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En HARTMANN marcarás la diferencia. Nuestros productos sanitarios y soluciones impactan cada día en la vida de millones de personas en todo el mundo – en hospitales, centros sanitarios, residencias, farmacias y en los hogares. Nos debemos a las personas y, por ello, confiamos en que vale la pena ir más allá ayudando a pacientes a gestionar su salud y a profesionales sanitarios a mejorar sus procesos.

Join our team as a

Clinical & Biocompatibility Expert

Mataró

 

 

 

Take advantage of your new scope of action in the Regulatory Affairs Area at PAUL HARTMANN S.A., Mataró. 


 

 

Responsibilities


Your area of responsibility:

  • Management, registration and implementation of the applicable legal requirements regarding Regulatory Affairs for products and activities developed by the company, specifically assuring compliance with MDD and MDR requirements for medical devices. 
  • Provide regulatory input to product lifecycle planning of medical devices, focus on MDD/MDR compliance.
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
  • Participate in risk-benefit analysis for regulatory compliance pre-market.
  • Assist with label development and review for compliance before release.
  • Provide regulatory input for product recalls and recall communications.
  • Support in Technical File Audits.
  • Become the Subject Matter Expert (SME) for Biocompatibility processes.
  • Maintains an excellent understanding of the global medical device regulations especially with respect to Biocompatibility for example ISO 10993, and by identifying and critically assessing emerging standards, theories and methodologies and applying gained expertise within the Biocompatibility processes, for products manufactured or commercialized by Hartmann Group and the specific requirements of the Spanish market (Place on the market in Spain).
  • Responsible for implementing regulatory requirements with respect to Biocompatibility.
  • Manage the technical documentation of medical devices under PHSA ownership and its clinical evaluation process and the files of LHSA (Legal Manufacturer) or other ones for third legal manufacturers under agreement
  • Assessment of Biocompatibility Requirements for new Products, Projects, Changes & Supplier Change notifications (SCNs) and ensuring the evaluation, determination, and documentation of biological safety for all products is maintained.
  • Coordination with external Biocompatibility laboratories on testing required and compilation of requirements to conduct same for example: samples, quotes, critical review of protocols and reports. 
  • Update of Biocompatibility Assessments on ongoing basis for new testing completed and documenting per SCNs /other changes.
  • Guarantee the compliance of Regulatory and Biocompatibility aspects for submissions for marketing Authorisations including responding to requests from Regulators.

 

 

What we look for

  • University degree on Engineering, Pharmacy or Biology. 
  • Understanding of applicable guidelines and regulations, for example experience with ISO 10993.
  • Strong knowledge of medical device regulations, in focus MDD and MDR legal requirements expertise.
  • Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
  • Minimum 1-3 years of experience in a regulated industry in a similar role.
  • Very good knowledge of Spanish and English written and spoken.


 

 

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. 

 

 

Department: Regulatory Affairs

If you are interested in the position, please it is necessary that 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