stillingsbetegnelse: Regulatory Affairs Officer for Oticon

jobbeskrivelse:
Do you have extensive experience with Regulatory Affairs? Would you like to use your skills and knowledge of regulatory processes in an international set-up with focus on the development of your professional and personal qualifications? Are you attracted by the possibility of becoming part of a highly qualified Regulatory Affairs team in one of the World’s leading companies within hearing solutions? Then we might have an exciting opportunity for you in our company. Supporting the organization In your new position, you will become a part of the Regulatory Affairs department. We are a small and dedicated team of 10 people situated in Denmark, Bern and Poland, 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, device and facility registrations, radio approvals, electrical safety approvals plus standard and regulation requirements. Furthermore, the team is involved in internal audit and system compliance according to EN ISO 13485 and FDA 21 CFR 820 and we are continuously involved in improvement projects. The job The position is central to the RA function and you can look forward to a wide range of challenging tasks. However your main responsibilities will be: Regulatory Affairs Projects Support, which includes managing and documenting the regulatory project strategy, classification and intended use, risk management file, standard requirements, technical file and review of marketing material. Regulatory Affairs tasks - senior level, which includes involvement in device and facility registrations, post market activities related to Risk Management File and Project Management within the Regulatory Affairs professional area. Your qualifications and experience In order for you to be a success in this job, it is vital that you have experience from similar jobs, preferably from a medical device or pharmaceutical industry. We expect you to hold a B.Sc. or M.Sc. in engineering (Medico, Electrical, Mechanical or similar) in combination with more than 5 years of experience with RA disciplines in relation to Medical devices, preferably in a large international organization. As a person, you are a self-motivated, outgoing, curious and analytically strong team player who is able to create and maintain good relations with stakeholders. You are adaptable and characterized by your drive and willingness to get things done. You are a good communicator who is capable of communicating naturally and presenting own knowledge and input in a strong and convincing way. Furthermore, you have a systematic approach to your work, you take leadership and facilitate complex meetings, and you have better than average ability to understand complex ideas, concepts and connections. We expect you to be fluent in English, both written and spoken, and very experienced MS Office, Database Systems and documentation systems user. You are able to travel up to 20 days per year. We dare to make a difference Together with ambitious and talented colleagues, you will be part of a dynamic environment based on trust and openness, and where you will experience a strong will to win. We are a growing international company where everyone supports the business in order to ensure that customers find that our products are the most attractive to work with. We are located in a light and open building, where flexible work environments, knowledge-sharing and mutual professional respect make it fun and meaningful to be here. Do you want to join the team? Then send your application no later then July 29. If you would like to learn more about the job, you are welcome to contact Kristine Klitgaard Pedersen, Manager Regulatory Portfolio on 3913 8583. We look forward to hearing from you. About Oticon 500 million people worldwide suffer from hearing loss. It is Oticon's ambition that our customers - hearing clinics

Arbejdsgiver Navn: OTICON A/S

Arbejdsgiver telefonnummer: 39177100

Arbejdsgiver faxnummer: 39277900

Job kort beskrivelse: Ingeniørarbejde i industri og produktion

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark