Regulatory Affairs Expert

Ihre Aufgaben

• Creation of GAP analyses as well as the creation and revision of technical documentation documents,

• preparation and implementation of software validations and verifications,

• strategic consulting on the organization and design of technical documentation and development documentation in accordance with IEC 62304, IEC 82304 and IEC 60601-1,

• creation of risk assessments with a focus on software, including information security,

• design and implementation of customer-specific workshops,

• communication and control at the interfaces (e.g. risk management and usability).

Ihr Profil

• have several years of experience in the documentation of medical software,

• know the software life cycle according to IEC 62304 and relevant regulations (MDR/IVDR),

• have a deep understanding of the design and architecture of medical software, as well as integration concepts,

• have experience in requirements management and verification/validation (incl. CSV) of medical software,

• have knowledge of information security,

• have a very good command of German and English.

Wir bieten Ihnen

We are always looking for employees for our technical documentation, clinical affairs, regulatory affairs and quality management departments. Do you appreciate flat hierarchies, a modern communication culture and a trusting working relationship? Then you've come to the right place! Do you want to develop further in your specialist area and also grow personally? Are you looking for flexible working time models and generous social benefits? Let's get together as soon as we can!,

• Teamwork makes the dream work: Open exchange, mutual support and respectful cooperation are a must with us and not just empty phrases.

• Freedom & personal responsibility: We offer you a modern working environment and benefits such as flexible working hours, mobile working, 30 days of vacation as well as disability insurance and an employee share in the company after one year of employment.

• We take time for your onboarding and never lose sight of you - you are not a personnel number with us, you are important to us. The figures prove it: we invest 2% of our annual turnover in the professional and personal development of our employees.

• We offer you a safe working environment with great people and exciting challenges - When will we meet?, Teamwork makes the dream work: open communication, mutual support and respectful cooperation are not just empty words for us. We offer a modern work environment with flexible hours and full mobility. You have the opportunity to participate in the company if you have been with Metecon for one year or more. We will fund your disability insurance if you have been with the company for at least one year. We take the time to get you started and never lose sight of you. We care about you, which is why we invest in your professional and personal development. Metecon offers a safe environment with great people and challenges.

Do you have questions about a job posting? Do you have expertise that we are not actively seeking, but that fits our portfolio?

Kontakt

Wiebke Hermanns Human Resources Manager Phone: +49 621 123469-044 E-mail: jobs@metecon.de, Wiebke HermannsPersonalmanagerinTelefon: +49 621 123469-044E-Mail: jobs@metecon.de, Then please contact our human resources manager, Wiebke Hermanns! She is always happy to take the time for you and will answer all your questions. And who knows: maybe your unsolicited application will become a completely new Metecon requirement? We look forward to talking with you! Please submit your speculative application

Wiebke Hermanns Human Resources T +49 621 123469-044 wiebke.hermanns@metecon.de