Mainz, Germany | full time | Job ID: 9918
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 main responsibilities:
* Coordinate and keep oversight over medical device or IVD medical device (study) co-submissions with BioNTech’s medicinal product candidates
* Manage 3rd party interactions when regulatory submissions are outsourced (e.g., to CROs)
* Ensure ongoing compliance with relevant global regulations and requirements (e.g., FDA 21 CFR Part 820 and EU IVDR (2017/746))
* Contribute to regulatory intelligence by monitoring, analyzing, and communicating changes in the emerging global regulatory landscape to ensure compliance and proactive strategic planning
* Manage regulatory assessments of product changes (during development and post-market) and changes in the global regulatory landscape potentially affecting BioNTech’s drug developments and/or approvals
What you have to offer:
Education and Professional Experience:
* Educational Background: Relevant higher education (e.g., Master's degree or PhD) or extensive professional experience (typically >5 years) in a related field
* Regulated Environment Experience: Proven experience working in regulated, quality-controlled environments (e.g., DIN EN ISO13485, GCP for laboratories). Experience in support of internal and external audits and inspections by regulatory authorities (e.g., FDA, Notified Bodies) and other third-parties is a plus
* Regulatory Documentation Expertise: Skilled in preparing and assembling regulatory documents (e.g., study submission packages for US FDA, EU IVDR) for medical devices or IVD medical devices, while integrating regulatory/health authority guidance and international standards into internal company documents
Your Skills:
* IVD Development Knowledge: Solid understanding of the IVD development process, including co-development of Companion Diagnostics (CDx) with medicinal products in regulated environments
* Regulatory Guidelines Familiarity: Knowledge of global regulatory/health authority guidelines (e.g., FDA, MDCG) and international standards (e.g., ISO20916), as well as clinical trial submission processes and medicinal product development
* Technical and Operational Skills: Proficient in MS Office, with desired expertise in design control, validation studies, risk management, and audit/inspection support (e.g., FDA, Notified Bodies)
* Leadership and Team Management: Proven ability to work independently and communicate effectively within cross-functional teams. Mentoring junior regulatory staff, fostering professional growth, and ensuring a high-performing team are considered valuable skills
* Communication Skills: Experience in effectively communicating with international Health Authorities and fluency in English (written and spoken)
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 9918 (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.