Regulatory Affairs Specialist

Regulatory Affairs Specialist

Miejsce pracy: Szczecin

Your responsibilities

• Maintaining technical documentation for the Medical devices including documentation for private label products.
• Managing and documenting the regulatory project strategy, classification and intended use, risk management file, standard requirements, and review of marketing materials.
• Participation in Regulatory projects.
• Attendance in design review of the design changes ECR. Performing risk evaluation of the design changes. Handling of ECO, updating documentation relating to ECO.
• Supporting the other teams (RAP, RACA, RAFR) with creation and review of project deliverables.

Our requirements

• experience with Regulatory Affairs or you work in the medical devices business or any other well-regulated areas (e.g. pharmacology) for at least a year will be an advantage;
• bachelor degree in medicine, chemistry, pharmacy or similar but your educational background is not decisive;
• experience of working with MS Office, Database Systems and documentation systems;
• good English skills enabling everyday communication;
• analytical and communication skills;
• ability to travel to Denmark at least two time per year;
• systematic approach to your work, willing to get things to be done;
• self-driven approach but the same time you are a strong team player who can develop and maintain good relations with stakeholders

What we offer

• full-time work employment with an international and growing organisation, with a permanent contract after 3 months;
• flexible working hours;
• a hybrid working model, combining remote work opportunities with our modern office located in the City Center of Szczecin;
• possibilities of learning and development opportunities, adapted to your needs and supporting your growth;
• various training and development programmes;
• daily use of English in an international environment;
• international business trips;
• competitive benefits package including social benefits (private medical health care, insurance, sport card etc.);
• possibility to join a team of high-performers where can-do-attitude, trust and honesty are the core values;
• Scandinavian culture – we are informal (we don’t use titles: Sir, Mr, Mrs, Miss…) and care about equality, independence, open dialog and work-life balance

Benefits

• sharing the costs of sports activities
• private medical care
• sharing the costs of foreign language classes
• sharing the costs of professional training & courses
• life insurance
• flexible working time
• fruits
• integration events
• no dress code
• coffee / tea
• pre-paid cards
• sharing the costs of tickets to the movies, theater
• sharing the costs of a streaming platform subscription
• employee referral program
• karta zniżkowa do pobliskich restauracji/sklepów
• dopłata do komunikacji miejskiej

Recruitment stages

• Rozmowa z Rekruterem
• Rozmowa z Rekruterem i Managerem
• Rozmowa z Managerem
• Spotkanie ofertowe

Demant Business Services

Would you like to work with products that actually change the lives of people worldwide and do it in a fast-growing company? Then we can offer you the right challenge! Right now, we are looking for a dedicated and skilled Regulatory Affairs Specialist to support Demant. If you already have experience with Regulatory Affairs or any other well-regulated areas it would be great, but not necessary.

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 capable of working in a dynamic and challenging international organization.

We are a small and dedicated team of 24 people situated in Poland and Denmark and we are responsible for the regulatory strategy for each project and for project support throughout the product development process.

Among other tasks, the team is managing classification activities, risk management file processes, clinical evaluation, device and facility registrations, radio approvals, electrical safety approvals plus standard and regulation requirements. Furthermore, the team is involved in external and internal audit and system compliance according to EN ISO 13485 and FDA 21 CFR 820 and we are continuously involved in improvement projects.

W przypadku aplikowania poprzez formularz znajdujący się w ofercie pracy, dane osobowe kandydata będą przetwarzane przez Demant Enterprise A/S jako administratora portalu rekrutacyjnego Demant. Pełna klauzula informacyjna dostępna jest w formularzu aplikacyjnym. ------------------------------------------------------------------------------------------------------------------------- Administratorem danych osobowych przetwarzanych w niniejszej rekrutacji jest Demant Business Services Poland Sp. z o.o. Pełna treść polityki prywatności znajduje się na naszej stronie internetowej Demant Polska w zakładce Polityka Prywatności.” Dane osobowe będą przetwarzane w celu przeprowadzenia procesu rekrutacyjnego na stanowisko wskazane w ofercie pracy. W przypadku wyrażenia zgody na przetwarzanie danych dla celów innych rekrutacji, dane osobowe będą przechowywane nie dłużej niż 12 miesięcy od ich ujawnienia, chyba że konieczność dłuższego przetwarzania danych wynikać będzie z przepisów prawa lub z prawnie uzasadnionego interesu administratora. Prosimy o zamieszczenie w CV informacji, czy wyraża Pan/Pani zgodę na przetwarzanie swoich danych osobowych dla celów innych rekrutacji: [] polskiej spółki z Grupy Demant, której dotyczy niniejsza oferta pracy, [] polskich spółek z Grupy Demant, [] wszystkich spółek z Grupy Demant. Wyrażenie zgody jest dobrowolne, jednak w przypadku braku jej wyrażenia nie będzie Pan/Pani otrzymywać ofert pracy za pośrednictwem ujawnionych danych kontaktowych. Ponadto informujemy, że w spółce obowiązuje procedura zgłoszeń wewnętrznych, która jest dostępna pod adresem: