20 beste Stellen als regulatory in rheinland pfalz – aktuell auf Personalsuche

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Manager Diagnostics Regulatory Affairs

BioNTech AG -
Mainz

Jetzt bewerben

Details zur Stelle

Vollzeit
vor 5 Tagen

Leistungen

Jobticket
Flexible Arbeitszeiten
Kostenfreies oder vergünstigtes Deutschland-Ticket

Qualifikationen

Doktorat
Master

Vollständige Stellenbeschreibung

Mainz, Germany | full time | Job ID: 11696

About the Role:

We are seeking a proactive and experienced Manager, Regulatory Affairs Diagnostics, to take charge of regulatory strategies and ensure compliance for BioNTech’s diagnostic and medical device products across the US, European Union, and other key global markets. This role demands hands-on expertise and a deep understanding of regulatory requirements, including FDA and EU IVDR, as well as experience in supporting regulatory submissions such as IVD performance study submissions. Operating with a high level of independence in a matrix organization, you will play a pivotal role in driving market access and supporting BioNTech’s drug portfolio worldwide.

Your Contribution:

Coordinate and oversee regulatory (study) co-submissions of medical devices or IVDs alongside BioNTech’s medicinal product candidates
Manage third-party interactions for outsourced regulatory submissions (e.g., CROs)
Ensure ongoing compliance with global regulations such as FDA 21 CFR Part 820 and EU IVDR (2017/746)
Monitor, analyze, and communicate changes in the global regulatory landscape to support proactive planning and compliance
Conduct regulatory assessments of product modifications during development and post-market phases
Support cross-functional teams with regulatory expertise to drive strategic goals

A Good Match:

Advanced degree (Master’s or PhD) or equivalent professional experience in a regulated environment (e.g., DIN EN ISO13485, GCP for laboratories)
Proven experience preparing regulatory documentation for medical devices or IVDs (e.g., study submissions to US FDA, EU IVDR)
Solid understanding of IVD development processes and co-development of Companion Diagnostics (CDx) with medicinal products
Familiarity with global regulatory guidelines (FDA, MDCG) and international standards (e.g., ISO20916)
Strong communication skills in English (written and spoken), with proficiency in MS Office tools
Ability to work independently within a matrix organization while mentoring junior staff is an advantage

Your Benefits:

It's our priority to support you:

Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare

Apply now - We look forward to your application!

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).

Job ID 11696 (please always specify if you have any questions)

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

www.biontech.com

Jetzt bewerben

Erweiterte Suche

regulatory Jobs in rheinland pfalz

Manager Diagnostics Regulatory Affairs

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