Junior Regulatory Affairs Manager Medical Devices – Export (m|f|d)
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Job Location:
Bergisch Gladbach - Germany
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Department:
Job Summary
As a Junior Regulatory Affairs Manager you will actively support the registration of medical devices in our Export regions specifically in countries managed by distributors with a focus on LATAM CIS and EMEA. Your work will be essential in ensuring regulatory compliance and facilitating market access across diverse international markets.
Your Key Responsibilities:
Marketing Authorization Files & Regulatory Pathways: You will assist in compiling and maintaining marketing authorization documentation based on product classification and help identify appropriate regulatory pathways for each region.
Change Assessment Process: You will support the initiation execution and/or supervision of change assessments including the evaluation transfer submission follow-up and documentation of change-related information.
Regulatory Compliance: In close collaboration with the Regulatory Affairs team and colleagues from Quality Assurance Quality Control Development and Production you will help ensure regulatory compliance across all relevant processes.
Understanding Regional Requirements: You will identify and interpret specific regulatory requirements and applicable standards in each target region acting as a key liaison between internal teams distributors consultants and regulatory authorities.
Qualifications :
- You have completed your Master degree in scientific or engineering studies preferably in the field of biology biotechnology or medical technology.
- You ideally have already gained first experience with regulatory affairs. Experience with medical devices would be of advantage.
- With your communicative manner and structured and accurate way of working you approach your tasks proactively and see yourself as a competent interface in all regulatory matters for your diverse contact partners.
- Cultural diversity excites you preferably you already gained first insights into an international business environment and are able to adapt to cultural characteristics easily.
- You are fluent in spoken and written English and German and can easily create reports and texts in these languages. Knowledge of Spanish language is a plus.
Zusätzliche Informationen :
What we offer
- Diversity: International teams and cross-border intercultural communication
- Room for creativity: Its the most clever solution that we always strive for
- Miltenyi University: A clever mind never stops learning take advantage of our inhouse Training Academy
Diversity is the bedrock of our creativity.
Our mission: To innovate treatments and technologies and tackle the worlds most serious health challenges. And thats why we connect the dots across various disciplines linking different perspectives skills and abilities.
You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender sexual identity age ethnicity religion or disability.
Become part of our team and focus on pushing the borders of medicine.
Contact us
If you have the skills and qualifications for this position please use the link to send us your details (application letter curriculum vitae). Please give us some idea of when you can start and the kind of salary you are looking for outlining the reasons you have made this application.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
For over 30 years, Miltenyi Biotec has been a major provider of products and services that drive biomedical research and boost cell and gene therapy. More than 4,700 employees in 23 countries combine excellence in research with innovative products to create cutting-edge solutions that ... View more
