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Regulatory Affairs Manager (m/f/d)

Eckert & Ziegler BEBIG GmbH
Berlin Headquarters
Presence / Mobile
Work experience

Quality Management, Quality Assurance
Fulltime
Published: 2025-12-19
Temporary

Regulatory Affairs Manager (m/f/d), 1. image

Regulatory Affairs Manager (m/f/d), 2. image

Regulatory Affairs Manager (m/f/d), 3. image

CONTRIBUTING TO SAVING LIVES | WIR HELFEN ZU HEILEN

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

We have been developing, manufacturing and marketing medical products for the treatment of cancer for more than 30 years. Our core business includes products for the treatment of prostate cancer and ocular tumours. Our many years of experience and expertise in brachytherapy, combined with our dedicated team of specialists, enable us to offer high quality products that are valued by clinics, doctors and patients worldwide.

Become part of our team, join us in the fight against cancer cells and help to heal.

Your contribution to success

Responsibility for the regulatory approval of medical devices in Europe and international markets
Creation, maintenance, and submission of the associated technical documentation
Provision, maintenance, and documentation of UDI data in accordance with the GS1 standard, as well as management of product registration in EUDAMED and international UDI databases
Monitoring, analysis, and implementation of regulatory requirements from laws, norms, and standards, as well as their periodic review
Coordination of cross-location approval projects in close cooperation with internal specialist departments
Communication and cooperation with national and international authorities, including maintenance of regulatory contacts
Evaluation, documentation, and reporting of product changes to relevant approval authorities
Further development and maintenance of regulatory QM processes, including standardization of technical documentation, labeling, and instructions for use

This qualifies you

Successfully completed degree in a technical, natural sciences, or economics field
Ideally, additional qualification in quality management or regulatory affairs, or in-depth further training in regulatory affairs
Several years of professional experience in the approval of medical devices, preferably in an international environment
Business fluent written and spoken German and English
Confident use of the MS Office package
Independent, structured, and meticulous approach to work, coupled with a high level of commitment and reliability
Strong teamwork and communication skills
Willingness to engage in continuous professional development

You can look forward to

Flexibility: working arrangements such as mobile working, flexible working hours and paid leave for specific reasons (e.g. moving house, cancer check-ups) to help you achieve the best work-life balance
Family friendly: Helping you balance family and career by offering paid time off for family events, such as sick days for children, parental start time or your own wedding.
Compensation package: Attractive compensation, plus savings plans and vouchers for benefits in kind or the JobTicket
Annual leave and time off: 30 paid vacation days for regular rest and recuperation
Workplace comfort: pleasant working environment with no open-plan offices or shift work, and ergonomic desks and chairs for comfort at work
Stability & Prospects: A secure job in an established company with long-term prospects and development opportunities.
Health promotion: company health management with CampusVital Card, health days and initiatives such as "Fit and active in the day" - the health of our employees is important to us
Mobility diversity: JobTicket, e-bike leasing, good public transport links, as well as company charging points for electric cars and the opportunity to recharge e-bike batteries free of charge for sustainable mobility

We look forward to receiving your application!

We’re always on the lookout for new talent and welcome every application — regardless of gender, age, background, sexual identity, disability, religion, or belief.
Diversity matters to us, and we value the unique perspectives you can bring to our company. Even if you don’t meet every single requirement listed in the job posting, we still encourage you to apply — because to us, individual skills, motivation, and potential are more important than ticking every box.
As part of the application process, you’ll have the opportunity to let us know if you have a disability or are considered of equal status under the law. We’re happy to adapt the process to suit your needs.

Show us what makes you unique. Take the next step in your career by applying through our online application form, which you can access via the “Apply now” button at the end of each job posting