Manager Diagnostics Regulatory Affairs

Job description

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.