You manage regulatory documentation and compliance for products, ensuring they align with global standards and commercial strategies, while overseeing approvals and providing strategic oversight for product changes.
Anforderungen
- •Bachelor's degree in Technical fields
- •Minimum 1 year in Regulatory Affairs or Quality Assurance
- •At least 2 years in development and manufacturing processes
- •Familiarity with ISO 13485 and ISO 14971 standards
- •Understanding of MDD 93/42/EEC and MDR 2017/745 regulations
- •Strong communication and interpersonal skills
- •Fluent in English, both written and spoken
Deine Aufgaben
- •Manage global regulatory product documentation.
- •Ensure compliance with regulatory standards and testing.
- •Coordinate regulatory approvals and change notifications.
- •Manage registrations, renewals, and submissions.
- •Coordinate regulatory strategies for FME products.
- •Oversee preparation of Free Sale Certificates and site registrations.
- •Lead regulatory aspects of product and process changes.
Deine Vorteile
Hybrid work option
Contribution to better medicine
Self-determined career opportunities
Innovative corporate culture
Diverse skilled colleagues
Global benefits with collegial culture
Original Beschreibung
# Regulatory Affairs Expert (m/f/d)
**Schweinfurt, Germany** | **Full time** | **Onsite**
Your responsibilities:
* Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling
* Ensure compliance with regulatory standards and testing requirements throughout product design and development
* Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities
* Ensure global regulatory product availability aligned with commercial strategy by managing registrations, renewals, and submissions
* Coordinate regulatory strategies for FME products and oversee preparation of Free Sale Certificates, declarations, and site registrations
* Lead regulatory aspects of product and process changes, including Declarations of Conformity, documentation, and marketing material reviews
Your profile:
* Bachelor’s degree in Technical, Engineering, or Scientific fields
* Minimum of 1 year in Regulatory Affairs or Quality Assurance in Medical Devices or Medicinal Products
* Knowledge of development and manufacturing processes (at least 2 years)
* Familiarity with quality management and risk management standards (e.g., ISO 13485, ISO 14971)
* Understanding of medical device regulations (e.g., MDD 93/42/EEC, MDR 2017/745)
* Strong communication and interpersonal skills
* Fluent in English, both written and spoken
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
Kindly be advised that this position is limited to 18-months.