Junior Regulatory Affairs Manager Medical Devices – Export (m|f|d) at Miltenyi Biotec

Bergisch Gladbach, North Rhine-Westphalia, Germany -

Full Time

Start Date

Immediate

Expiry Date

06 Jan, 26

Salary

0.0

Posted On

08 Oct, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Devices, Compliance, Documentation, Change Assessment, Communication, Cultural Diversity, English, German, Spanish

Industry

Biotechnology Research

Description

Unternehmensbeschreibung For 35 years, we have been developing cutting-edge science and technology to empower biomedical research and personalized medicine. We combine excellence from more than 60 disciplines in natural sciences, engineering, and informatics to significantly contribute to biomedical sciences. We encourage a creative working environment driven by pioneering spirit – to seek new horizons – boldly envisioning the future and turning it into reality. Today, more than 4,800 experts from over 50 countries contribute to our sustainable success. Stellenbeschreibung 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. Qualifikationen 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: It’s 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 world’s most serious health challenges. And that’s 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.

Responsibilities

As a Junior Regulatory Affairs Manager, you will support the registration of medical devices in export regions, ensuring regulatory compliance and facilitating market access. You will assist in compiling marketing authorization documentation and identifying regulatory pathways for various regions.