The bredent group is a leading family business with strong values, clear goals and a future-oriented vision in the dynamic dental market. We have now been in existence for 50 years and have an innovative and committed team of 640 employees worldwide. We offer you the opportunity to become part of our success story!
YOUR QUALIFICATION
- Bachelor’s or master’s degree in science or technical discipline or equivalent qualification
- Professional experience in regulatory affairs field in the medical device industry or similar industry sector
- Experience with submissions for medical devices in countries outside the EU e.g. USA, Asia, UK
- Knowledge of regulation (EU) 2017/745 (MDR), ISO 13485, MDSAP is desirable
- Strong analytical and problem-solving skills, including ability to understand regulatory requirements and implement them in efficient and pragmatic way
- Strong communicative, collaborative and organizational skills
- Very good written and spoken skills in English
- Very good knowledge of MS Office applications
YOUR RESPONSIBILITIES
- Planning, coordination and implementation of product registration projects for countries outside the EU, as well as preparation, review and submission of related documentation
- Communication with regulatory authorities, distributors and regulatory service providers
- Maintain corresponding data in the local ERP system and international databases
- Maintain and update existing approvals
- Ensure compliance with applicable national and international regulatory requirements
- Proactively monitor, identify and implement regulatory developments, guidelines, and requirements related to the registered products
- Provide regulatory guidance and compliance requirements to multi-disciplinary teams
- Support during audits and inspections
YOUR BENEFITS
- A permanent employment contract
- Flexible working hours and the option to work from home
- 30 days of vacation per year and special leave days for various occasions
- Individual development and promotion opportunities
- JobRad leasing option
- TicketPlus voucher card or EGYM Wellpass
- Corporate Benefits
- Employer subsidy for company pension scheme and lunch
- Very good connections due to surrounding highways and public transportation
- Free employee parking spaces
- Regular team events and information events
- Material cost subsidy for dental treatment for employees and relatives
Are you interested? We look forward to receiving your detailed application by e-mail to bewerbung@bredent.com. If you have any questions, please contact Ms. Natalie Ziegler, +49 7309 872-357.
