Director of Digital Reporting and Compliance at Clearsulting leading finance teams in multi - billion dollar problem solving. Ensuring effective technical solutions and guiding client onboarding to Workiva platform.
About the role
- Manage the certification processes for medical devices, ensuring compliance with EU regulations and supporting internal teams on regulatory issues. Requires expertise in engineering and medical device certification.
Responsibilities
- Manage the technical aspects and coordinate the CE certification process for medical devices in accordance with Regulation (EU) 2017/745 (MDR);
- Support the preparation and review of technical files and compliance documentation;
- Liaise with notified bodies, competent authorities and external partners;
- Ensure implementation and maintenance of the quality management system (ISO 13485);
- Serve as Technical Responsible (Responsible Person) to INFARMED and other regulatory authorities;
- Support internal teams (R&D, Production, Marketing) on regulatory and quality matters.
Requirements
- University degree in Biomedical Engineering, Pharmaceutical Sciences, Biotechnology or a related field;
- Proven experience (min. 3 years) in CE marking processes for class IIa, IIb or III devices;
- Solid knowledge of the MDR (2017/745) and ISO 13485;
- Experience in the ophthalmology market is a plus;
- Project management and planning skills, with experience liaising with external entities;
- Fluency in Portuguese and English (written and spoken);
- Strong sense of responsibility, attention to detail and ability to work autonomously.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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