The Regulatory Affairs team is responsible for the registration of our products in the markets in which we operate. We are experiencing a rapid growth and since the world-wide regulatory requirements are increasing, an expansion of the regulatory affairs team is necessary. Our team assists our six brands that develop and manufacture hearing test equipment focusing on advanced diagnostic products used for fitting hearing aids, auditory brainstem audiometry and balance assessment. These brands are homebased in USA, Germany, UK and Denmark.
We are looking for a candidate to fill in the position of a Regulatory affairs specialist – to be a member of our professional regulatory affairs team that consists of 3 colleagues in Poland and 3 colleagues in Denmark.
The ideal candidate has already had experience within registration or technical file work in the medical devices business or within other similar well-regulated areas (e.g. pharmacology) for at least a year.
You may have a bachelor’s degree in medicine, chemistry, pharmacy or similar but your educational background is not decisive.
It would be great if you:
- are familiar with regulatory requirements for medical devices – in Europe (MDD/MDR), USA (FDA) and/or other local requirements around the world;
- are fluent in English, both written and spoken, and you have very good communication skills;
- have a sense for details without losing the overview;
- are a self-managed and organized person and have a structured and disciplined work approach.
Being part of our team your main tasks will be to:
- prepare product documentation needed for the product registrations of diagnostics equipment - typically class IIa medical devices;
- communicate with the R&D and other departments about the necessary registration documents;
- communicate and cooperate closely with stakeholders internally and around the world to register products for sale;
- give support on customer enquires;
- monitor and communicate changes in country specific regulatory requirements;
- further develop our best way practices within regulatory affairs;
- participate in regulatory projects and provide input to projects across departments and brands;
- travel to Denmark for training and coordination purposes when required - on average 2-3 times a year.
Working with us gives you the opportunity not only to plan your own work and be largely self-managed, but also to become a part of an experienced team of specialists working in a dynamic and challenging international organization.
We offer you:
- internal as well as external training and development – both within soft skills and professional skills;
- possibility to use and improve English on daily basis in our international environment;
- possibility for career development;
- business trips and teamwork across borders – DK/PL;
- flexible working hours and a work-life balance approach - DGS BS gained several awards for being a good place to work;
- a very convenient location of our offices - in the city center of Szczecin.
Please write a cover letter and CV in English, adding the clause: in accordance with the Law of Personal Data Protection of 29.08.1997 (Journal of Laws No. 101, item 926) I give my consent to processing of my personal data contained in the offer for the recruitment process in DGS Poland Sp. z o.o. and DGS Business Services Sp. z o.o.
We do not return the applications. We will contact selected candidates.