Manager Diagnostics Regulatory Affairs (Mainz, RP, DE, 55131)
About this opportunity
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.
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Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 192 comparable Manager Regulatory Affairs roles across 64 biopharma companies.
Salary context
52 of 192 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 192 comparable roles
+ 27 more countries
Seniority mix
192 of 192 peers have a known seniority level
Therapeutic area mix
16 of 192 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.