bredent group

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)

YOUR RESPONSIBILITIES

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

YOUR QUALIFICATION

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

YOUR BENEFITS

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

CONTACT

Are you interested? Then we look forward to receiving your detailed application!
If you have any questions, please contact Ms. Natalie Ziegler, +49 7309 872-357.

bredent GmbH & Co.KG
Weissenhorner Straße 2
89250 Senden
Tel.: +49 7309 / 872-0
Fax: +49 7309 / 872-24
EMail: email

Apply now

Full-Time , Permanent

Specialist

Updated at 10/02/2024

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