Manager Diagnostics Regulatory Affairs

Gudejobs; Mainz; Vor Ort; EUR 90.000 - 140.000; Vollzeit

Benefits dieser Stelle

Flexible hours

Vacation account

Digital Learning

Performance & talent development

Leadership development

Apprenticeships

LinkedIn Learning

Voice at the table

Culture on an equal footing

Opportunities to shape & impact

Support for your full potential

Company bike

Job ticket

Deutschlandticket

Employer-funded pension

Childcare

Zusammenfassung

BioNTech is recruiting a Manager, Regulatory Affairs Diagnostics to lead regulatory strategies for diagnostic and medical device products across the US, EU, and global markets. You will manage regulatory submissions, coordinate with CROs, and ensure compliance with FDA and EU IVDR requirements.

The role requires hands-on regulatory expertise, strong communication, and the ability to mentor junior staff within a matrix organization, supporting BioNTech’s drug portfolio worldwide.

Qualifikationen

• 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).
• Familiarity with global regulatory guidelines (FDA, MDCG) and ISO standards.

Aufgaben

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

Kenntnisse

Regulatory documentation

IVD/CDx development

Global regulatory guidelines

English communication

MS Office proficiency

Mentoring

Ausbildung

Advanced degree in a regulated environment

Jobbeschreibung

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

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, encouragecreativity, 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