The companyOur client is a professional Medical Devices organization, based in Zuid-Holland Netherlands. Ophthalmic medical devices company.
Role descriptionAs a Medical Regulatory Affairs Specialist, you will be responsible for drafting and maintaining the technical documentation for ophthalmic medical devices. You will ensure that this information is delivered to the regulatory body on time to obtain CE marking.
Responsibilities- Obtaining CE marking for medical ophthalmic products;
- Interpreting and implementing international legislation and standards;
- Converting standards and legislation to requirements for product development, manufacture and document management;
- Advising on strategy and tactics for submitting technical files;
- In conjunction with the R&D, sales & marketing and manufacturing departments, establishing registration requirements as a critical part of the technical files;
- Conducting literature studies to collect clinical evidence;
- Contributing to the risk management process and seeing to it that sufficient evidence is delivered to ensure that the preventive and corrective measures are effective;
- Drawing up and assessing protocols for verification and validation activities;
- Outsourcing work to test laboratories with the correct accreditation for supporting documentation;
- Advising and supporting the departments concerned on scientifically sound methods for providing statistical evidence;
- Drawing up and assessing product-related documents such as labels, layouts, inserts, promotional materials, instruction manuals for use and maintenance of products.
- Supervising progress to obtain a full technical dossier;
- Responding to questions and comments from the regulatory authorities in line with the objectives;
- Ensuring unity and recognisability in the documentation;
- Composing, keeping up-to-date and managing technical files.
Requirements- An ability to think and work at HBO level, medical/technical background;
- Proven project management skills;
- Helicopter view, steering and where necessary making adjustments to registration projects;
- Experience with putting together a technical file for medical devices for Class I, IIa and IIb products;
- Experience with BSI is a plus;
- An affinity with technical and medical surgical technology;
- Knowledge and understanding of risk-based verification and validation documentation;
- Thorough and current knowledge of European, USA and Japanese laws and regulations for medical devices;
- Attention to detail with a good insight into key and adjacent areas;
- Good communication skills in both Dutch and English;
- Understanding of documentation in German;
- Proactive personality with a sense of responsibility for attaining results;
- Natural deadline-oriented mentality;
- A pragmatic mentality and ability to contribute to the progress of documentation processes;
- An ability to work both independently and in a team;
- Project-based mentality, results-oriented, precise, alert and accurate.