Manager Diagnostics Regulatory Affairs (Mainz, RP, DE, 55131)

Biopharma Careers; Mainz; Vor Ort; EUR 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Flexible hours

Vacation account

Digital Learning

Performance & talent development

Leadership development

Apprenticeships

LinkedIn Learning

Voice at the table

Company bike

Job ticket

Deutschlandticket

Employer-funded pension

Childcare

Zusammenfassung

BioNTech is seeking a proactive Manager, Regulatory Affairs Diagnostics to lead regulatory strategies for diagnostic devices and companion diagnostics across the US, EU, and other key markets. You will work in a matrix environment, ensuring compliance with FDA and EU IVDR and supporting submissions for performance studies.

The role requires an advanced degree, proven experience in medical devices or IVD regulations, and strong English communication.

Qualifikationen

• Advanced degree in a regulated environment (e.g., DIN EN ISO13485, GCP for laboratories).
• Experience preparing regulatory documentation for medical devices or IVDs (e.g., study submissions to US FDA, EU IVDR).
• Familiarity with global regulatory guidelines (FDA, MDCG) and international standards (ISO20916).

Aufgaben

• Coordinate and oversee regulatory co-submissions of medical devices/IVDs with 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 regulatory landscape changes to support planning and compliance.
• Support regulatory assessments of product modifications during development and post-market.

Kenntnisse

English proficiency

MS Office

Ausbildung

Advanced degree (Master’s or PhD) in regulated environment

Tools

MS Office

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:

• flexible hours | vacation account
• Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your 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

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.

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