September 20, 2024

B. BRAUN SHARED SERVICES SRL

Post Market Surveillance Specialist MD HC_2 years

Creation, updating and transmission of vigilance reports to the competent authorities and support for the Post Market Surveillance (PMS) system for Medical Devices, Hospital Care division.

Duties and responsibilities

Creation and updating of PMS plans for the EU;
Creation and updating of PSUR / PMSR for the EU;
Creation and updating of PRER for China;
International cooperation within the PMS process within the division.
International communication with authorities in the context of reportable incidents regarding Hospital Care division;
Creation, checking and maintenance of quality-relevant documents (reports, SOPs, forms);
Support in cross-interface cooperation with various areas such as QM, R&D, production, marketing and sales;
Support in the further development and optimization of the PMS system / vigilance management system;
Regular travel to Germany.

Professional competencies

Academic degree (Bachelor or Master) or comparable education;
Background in medical engineering, natural science (Pharmacy, Chemistry, Biochemistry, Biology, Medicine or related fields) or quality management;
2 years working experience in Quality Management and / or regulation for Medical Devices, ideally in an interface process such as change control is an advantage;
Knowledge of database operation – SAP databases is an advantage;
Regulatory Knowledge for EU Medical Devices desirable (. EN ISO 13485; EU Regulation; 21 CFR; NMPA Directives etc.);
Fluency in English (written and verbal); German is an advantage;
Microsoft Office package (. Word, Power Point, Excel) - independent user; Adobe Professional / Nuance
Good organizational skills, attention to detail and capable of fast learning;
Excellent communication, teamwork skills and flexibility.

Personal competencies

Demonstrates a positive attitude and thinks in terms of solutions
Works in complex structures successfully
Act analytically and systematically

What we offer

Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.

Benefits

Fix-term contract of 2 years;
Annual performance bonus;
Work from home most of the time (80%) – Office work takes place in Sânandrei, Timis County;
Meal tickets;
Health subscription (free or discounted medical services);
7 Card subscription;
A premium for family events, according to the Collective Labor Agreement;
Settlement costs for the purchase of eyeglasses;
Free coffee and dynamic work atmosphere.