Regulatory Affairs Manager - Parental Leave Cover (m/f/d)

Eckert & Ziegler BEBIG GmbH is part of the renowned and internationally active Eckert & Ziegler Group, a world leader in nuclear medicine.

For more than 30 years, we have been developing, producing and distributing medical devices for the therapy of cancers. Our core business includes products for the treatment of prostate cancer and ophthalmological tumors. Our many years of experience and expertise in brachytherapy, combined with our dedicated team of professionals, enables us to offer high-quality products that are appreciated worldwide by clinics, doctors and patients.

Become part of our team, together with us take up the fight against cancer cells and help cure.

Responsibility for regulatory approval of medical devices in Europe and international markets Creation, maintenance and submission of related technical documentation Provision, maintenance and documentation of UDI data according to GS1 standard and management of product registration in EUDAMED and international UDI databases Monitoring, analysis and implementation of regulatory requirements from laws, standards and standards and their periodic review Coordination of cross-site admission projects in close cooperation with internal specialist departments Communication and cooperation with national and international authorities, incl. Care of regulatory contacts Assessment, documentation and notification of product changes to relevant certification bodies Further development and maintenance of regulatory QM processes, including standardization of technical documentation, markings and instructions for use

Successfully completed studies in technical, natural or economic sciences Ideally additional qualification in quality management or licensing, or well-founded further training in regulatory affairs Multiannual professional experience in the approval of medical devices, preferably in an international environment German and English knowledge in word and writing Safe handling of the MS Office package Self-contained, structured and careful working together with high operational readiness and reliability Embossed team and communication skills Ready to continue professional training

Flexibility: design of working hours through mobile work, flexible working hours and decent-related paid allowances (e.g. moving or dates for cancer provision) for an optimal work-life balance Family-friendliness: support in the reconciliation of family and profession, through paid allowances for family events, such as child-hospitable days, family start time or your own wedding Compensation package: Attractive remuneration as well as asset-effective services and property vouchers or JobTicket Holiday and recreation time: 30 days holiday for regular rest and to recharge energy Work comfort: pleasant work environment without large-scale office and ergonomic tables and chairs for comfort at work Stability & Perspective: Safe workplace in an established company with long-term prospects and development opportunities Health promotion: occupational health management with CampusVital Card, health days and actions like ''Fit and active in the day'' - the health of our employees is at our heart Variety of mobility: JobTicket, e-bike leasing, a good ÖPNV connection as well as company-owned charging stations for e-cars and the possibility of free charging of e-bike batteries for sustainable mobility