Regulatory Manager
We are collaborating with a global CRO to find an experienced Regulatory Manager to join their Consumer Health partner, specifically focusing on Medical Devices.
The Regulatory Manager will be essential in ensuring compliance with EU regulations for various medical devices, including substance-based devices, combination products, and measuring devices.
This role requires monthly travel to Düsseldorf for training and prior experience in supporting ISO audits
The contract will be 40 hours per week, for an initial 6 months contract (open to extension)
Primary Responsibilities and Duties :
- Ensure adherence of all medical devices to EU regulations, including the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
- Support ISO audits by ensuring conformity with ISO 13485 and other applicable standards.
- Prepare and update regulatory documentation such as Technical Files and Design Dossiers.
- Oversee regulatory submissions and compliance for substance-based devices, ensuring all requirements are met.
- Manage regulatory submissions and compliance for combination products.
- Ensure regulatory adherence for medical measuring devices.
- Collaborate closely with R&D, manufacturing, and quality assurance teams, providing regulatory guidance throughout the product development and lifecycle stages.
- Stay informed about changes in medical device regulations and standards, and communicate updates to internal teams.
- Provide training and support to internal teams regarding regulatory requirements and best practices.
Qualifications, Experience, and Skills :
Bachelor's degree in a scientific or engineering field such as Biomedical Engineering, Chemistry, Biology, or a related discipline.
An advanced degree is preferred.
- At least 5-7 years of experience in regulatory affairs within the medical device industry.
- Comprehensive knowledge of EU medical device regulations and guidelines, with experience in substance-based devices, combination products, and measuring devices being essential.
- Demonstrated experience in supporting ISO 13485 audits and ensuring compliance.
- Strong analytical and problem-solving capabilities.
- Excellent communication and interpersonal skills.
- Ability to work effectively as part of a team.
- Exceptional attention to detail and organizational skills.
- Proficiency in both English and German is essential
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