Jobbeschreibung
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!
Join our team as soon as possible as our new
Regulatory Affairs Specialist / Manager (m/f/d)
- Planning, coordination and implementation of product registration projects for non-EU countries including the preparation, review and submission of related documentation
- Communication with regulatory authorities, service providers and distributors
- Keep local ERP data in sync with 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
- Bachelor's or Master's degree in a scientific or technical discipline or an equivalent qualification
- Professional experience in regulatory affairs in the medical device industry or a similar industry sector
- Experience with submissions for medical devices in countries outside the EU, e.g. USA, Asia, UK
- Ideally knowledge in the regulations (EU) 2017/745 (MDR), ISO 13485 and MDSAP
- Strong analytical and problem-solving skills, including the ability to understand regulatory requirements and implement them efficiently and pragmatically
- Strong communicative, collaborative and organizational skills
- Excellent command of written and spoken English
- Very good knowledge of MS Office applications
- A permanent employment contract
- Flexible working hours and the option to work from home
- 30 vacation days per year and special leave days for various occasions
- Individual development and promotion opportunities
- JobRad leasing option
- Ticket Plus voucher card or EGYM Wellpass
- Corporate benefits
- Employer subsidy for company pension scheme and lunch
- Excellent commuting both by car and public transport
- Staff parking free of charge
- Regular team events and information events
- Material cost subsidy for dental treatment for employees and relatives