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Regulatory Affairs Specialist. Dinamarca

Demanda de Ingenieros en Dinamarca

Clasificación del trabajo: Profesionales científicos e intelectuales : Profesionales de las ciencias y de la ingeniería : Ingenieros (excluyendo electrotecnólogos) : Ingenieros no clasificados bajo otros epígrafes.

Arbejde, der forudsætter viden på højeste niveau inden for pågældende område : Arbejde inden for naturvidenskab og ingeniørvirksomhed : Ingeniørarbejde (undtagen inden for elektroteknologi) : Andet ingeniørarbejde (undtagen elektroteknologi)

Descripción de la oferta de trabajo:

Are you ready to make a change in your life and join one of the world’s most famous companies within IVF solutions, based in Denmark? We are a global company operating within the IVF medical field, providing various solutions for the In Vitro Fertilization laboratories. We own one of the most known and widely recognized brands on the market, influencing fertility processes and pregnancy rates around the globe. Our team is engaged to ensure top quality products and fast supply every day. We are looking for a Regulatory Affairs Specialist in Farum, Denmark (great Copenhagen area). You will ensure that everything is in order according to instructions, guidelines, and regulations, and we will help you settling down in this beautiful country!

The job: 

You will be a part of the Regulatory Affairs department. You will be responsible for ensuring product compliance with various new or updated regulatory requirements (e.g. MDD 93/42/EEC). Directly preparing and maintaining the technical file documentation. Supporting distributors about the company’s products in various technical matters.

Our job requirements are:

  • good research and data analysis skills
  • ability to multitask and prioritize
  • understanding quality management system principles
  • knowledge of ISO 13485 standard
  • knowledge of Medical Device Directive 93/42/EEC
  • knowledge of CE marking process (experience is an advantage)
  • experience with preparing and maintaining technical files
  • experience with audits and Notified Bodies

Your main responsibilities will be:

  • Preparing and maintaining technical documentation;
  • Conducting Post-Market Surveillance;
  • Maintaining a Quality Management System for the Regulatory Affairs Department;
  • Researching and supporting distributors with various issues related to the company’s product;
  • Assuring product compliance with relevant regulatory requirements (medical device, biocides);
  • Supporting other departments when needed.

Qualifications and experience:

A Bachelor’s or Master’s degree in science or engineering field. It is an advantage to have work experience within the medical device sector, e.g. from direct employment, internship, graduate program, or consultancy.

You have an analytical mind-set and systematic approach to your work. You are a team-player and like to be challenged. Ability to communicate with people with different backgrounds and work positions is necessary for this position. Excellent communication skills in written and spoken English are required.

Knowledge of standards ISO 9001, ISO 14971, EN 62366-1 is an advantage.

Working at SparMED: 

 

The commitment and ambition of our employees help us to successfully operate within the In Vitro Fertilization field influencing pregnancy rates around the globe. In return we offer:

 

- Assistance with registration at arrival in Denmark (work permit, health insurance)

- A wide range of opportunities for professional development through training courses, exhibitions, IVF annual meetings etc.

- An informal international work-environment

- Flexible working hours

- Extra vacation days

- Sick, personal, and parental leave

- Health insurance

- Retirement plan

 

Contact:

For further information, please contact Agnes Bugno at agnessparmed.dk.

País del trabajo: Dinamarca.

Número de puestos: 1.

Tipo de puesto: Contratación directa.

Tipo de contrato: Jornada completa.

Empleador: SPARMED ApS.

Instrucciones para solicitar:

Please apply using one of the specified channels

Forma de contacto:

  • Ciudad: Stenløse; Código postal: 3660; Calle: Toppevadvej, Número: 34
  • Correo electrónico: agnessparmed.dk

Identificador de la vacante:4918043.

Ver las 190 ofertas de trabajo de Profesionales científicos e intelectuales : Profesionales de las ciencias y de la ingeniería : Ingenieros (excluyendo electrotecnólogos) : Ingenieros no clasificados bajo otros epígrafes ofertadas.

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