Vigliance Specialist 80 - 100 %

Vigliance Specialist 80 - 100 % (w/m/d)
True to the vision "We drive innovation to improve people's lives", the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the field of ventilators.
Hamilton Medical is a leading manufacturer of intelligent ventilators. Whether in ICUs, during emergency rescue transport or an MRI scan - our solutions cover a multitude of patient groups, applications and environments.
How you can make a difference:
Reportability Assessment
Creation of initials reports in a timely manner
Ownership on deadline to conduct tasks as per given timeframe from the applicable requirements
Creating final reports based on investigation
Sense of communication with diverse stakeholders internally or externally
Communication with health competent authorities with a certain complexity level
Prepare overviews of reported events for notified body or competent authorities
Prepare statistics for yearly management review
Participate at audits and inspections
Provide support on processes' improvements
Support team members on daily tasks acting as a coach
That's what you bring along:
Strong experience in Post-Market Surveillance, with focus on Vigilance (Reporting tasks), i.e., analyzing need for reportability, creating initials, follow up in a timely manner and create final reports based on the provided investigation
Capability to communicate with health competent authorities
Being able to challenge the quality of data provided and ensure data integrity
Knowledge with quality systems such as complaint handling and CAPA
Solid Knowledge on medical devices regulations (EU-MDR 2017-745, FDA 21CFR 803 and MDSAP countries)
Fluent in English and German
Good communication and problem-solving skills
Structured methodology for good documentation practices
Willing to be curious and to learn
Ability to set up priorities and acting in a timely manner
How to apply:
Learn more about career opportunities at Hamilton at Jobs | Hamilton Medical.
Do you share our values and feel at home in a cooperative, innovative,and down-to-earth environment? At Hamilton, we not only offer a motivating working environment, but also purposeful workand modern working conditions. Our interactions at eye level encourage open communication and a pleasant working environment. Become part of a team where your skills are valued and innovative ideas are fostered. Interested? Then apply online using the "Apply now" button. If you have any questions, please contact us at E-Mail schreiben with the following details:
Reference: JR-5606-fjm/Contact: Juli
Applications by post or e-mail can unfortunately not be considered. jid53c4cabpn jit0311pn jiy26pn