Publication date: 16 May 2019

Junior Quality/ Regulatory Specialist

Roche Polska

Language:

Category: IT

Level of English: C1-C2

Ref. no.: 201810-124030

Position level: Specialist

What is Roche?

Founded in 1896
Employs over
90,000 people
Helps millions
of patients
Innovative
pharmaceuticals
and diagnostics
 

We are the IT center for Roche - a company in top 10 biggest R&D spenders worldwide.
We do #Code4life creating innovative software that helps doctors, patients and scientist around the world.

Junior Quality/ Regulatory Specialist

Location: Warsaw Wybrzeze Gdynskie, Poland 

Main responsibilities:

  • Support in implementation and maintenance of regulatory, quality and safety compliance for IVD medical devices and support in providing guidance for regional and local business partners, including Polish affiliate and Management Center Poland and East Europe countries;
  • Communicating effectively with distributors’ contacts, global and local quality/ regulatory groups on a daily basis with regards to regulatory and quality aspects;
  • Administration of regulatory, quality and safety related training in Polish and in English;
  • Acquiring knowledge of regulations, guidelines, procedures and policies relating to the distribution of IVD medical devices;
  • Support in monitoring regulatory intelligence and acting proactively on identified changes to regulatory requirements (i.e. support with submissions);
  • Accomplishment of routine assigned project assignments and providing data assessment and conclusions within the department;
  • Working on improvement opportunities for regulatory, quality and safety processes, policies and systems;
  • Playing an active role in product quality issues, including medical devices vigilance, in order to minimize the impact on business;
  • Providing support for all audits and inspections as needed and participating/ conducting internal audits.

This role requires:

  • Life Science or technical related field educational background;
  • Experience in Regulatory or Quality area (experience with medical devices/ IVD medical devices, preferably);
  • Excellent command of written and spoken English;
  • Ability to handle multiple tasks and to prioritize and schedule work to meet business needs;
  • Detail-oriented, with emphasis on consistent delivery to time, cost and quality standards;
  • Excellent interpersonal skills (including presentation skills); ability to communicate, work in a diverse team environment and build relationships across a large organization;
  • Basic understanding of National and EU medical devices and IVD medical devices directives, regulations and requirements;
  • Knowledge of quality assurance standards would be an asset;
  • Ability to work independently with limited supervision;
  • Excellent command of MS Office applications.

We offer:

  • Employment based on a contract of employment;
  • attractive social package;
  • work in an international environment;
  • the possibility of professional development.

If…

 

You’re someone who wants to influence his own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, where a job title is not considered the final definition of who you are but only the starting point.

 

Ideally you come from a similar working background, where handling problems and dealing with queries from the healthcare area is familiar to you.

 

You are a person who is passionate about providing a good service and works well within an international team environment.

 

The next step is yours. To apply today send your CV via button Apply Now until 23rd of October 2018.

Interested?
...The next step is yours
We reserve the rights to reply only to chosen applicants.

Roche is an equal opportunity employer. We care about inclusion in terms of gender, age, race, skin colour, nationality, religion, marital status, sexual orientation, background, physical or mental disabilities and on every other grounds. Applying for our position, we assure you that we will assess your application solely on the basis of your competencies.
Check Roche Polska profile


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