You oversee regulatory documentation and ensure compliance for global product registrations. Your role involves strategic coordination, aligning stakeholders, and collaborating on clinical evaluations.
Anforderungen
- •Technical background (PhD, MBA, or relevant education)
- •Minimum 1 year experience in Regulatory or Quality Assurance
- •2+ years knowledge in development of Medical Devices
- •Familiarity with ISO 13485 and FDA 21 CFR
- •Understanding of medical device regulations (MDD, MDR)
- •Knowledge of Quality Management requirements
- •Expertise in sterilization processes and validation methods
- •Regulatory knowledge on global registration
- •Fluent in English and German
Deine Aufgaben
- •Manage global regulatory documentation creation and maintenance.
- •Support global product registrations and submissions.
- •Ensure compliance and perform conformity assessments.
- •Provide regulatory input for design changes.
- •Coordinate global regulatory strategies and communications.
- •Lead regulatory impact assessments and stakeholder alignment.
- •Support creation and review of marketing materials.
- •Collaborate on clinical evaluation content and risk evaluations.
- •Assist with registration of manufacturing sites and submissions.
Deine Vorteile
Hybrid work option
Contribution to better medicine
Opportunities for career development
Culture of innovative thinking
Commitment from skilled professionals
Benefits of a global corporation
Original Beschreibung
# Regulatory Affairs Expert (m/f/d)
**St. Wendel, Germany** | **Full time** | **Onsite**
We are looking for a Regulatory Affairs Expert - Critical Care/Peritoneal Dialysis (m/f/d) in Bad Homburg or St. Wendel.
Your responsibilities:
* Manage creation, maintenance, and approval of global regulatory documentation (e.g., technical files, registration dossiers, labeling, IFUs)
* Support global product registrations, renewals, and submissions, including compilation of STED files, declarations, and Free Sale Certificates
* Ensure compliance with applicable standards, perform conformity assessments, and align product risk classifications
* Provide regulatory input for design changes, development projects, and change control processes
* Coordinate global regulatory strategy, activities, and communications across markets
* Lead regulatory impact assessments, change implementation, and stakeholder alignment
* Support creation and review of Declarations of Conformity, marketing materials, and product-related documentation
* Collaborate on clinical evaluation content and provide expert opinions and risk evaluations
* Assist with registration of manufacturing sites, kits, and trading goods; support tenders and pharma-related device submissions
Your profile:
* Technical/Engineering/Scientific background (PhD, MBA, or relevant specialized education)
* Minimum 1 year professional experience in Regulatory or Quality Assurance for Medical Devices/Medicinal Products
* 2+ years knowledge in development, manufacture, and control of Medical Devices/Medicinal Products
* Familiarity with quality management and risk management standards (e.g., ISO 13485, ISO 14971, EU GMP Guidelines, FDA 21 CFR §820.250)
* Understanding of medical device regulations (MDD 93/42/EEC, MDR 2017/745)
* Knowledge of internal/external processes and corporate Quality Management requirements
* Expertise in sterilization processes, clean room requirements, and validation methods
* Regulatory knowledge on global registration
* Fluent in English and German
Our offer for you:
There is a lot you can discover at Fresenius Medical Care, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:
* The option to work on a hybrid basis
* Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
* Individual opportunities for self-determined career planning and professional development
* A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
* A large number of committed people with a wide range of skills, talents and experience
* The benefits of a successful global corporation with the collegial culture of a medium-sized company