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Documentation Specialist (Medical Devices)

SIRE Life Sciences®

Netherlands, zagranica

SIRE Life Sciences®

Documentation Specialist (Medical Devices)

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Zuid-Holland Netherlands.

The organisation produces medical devices for over eighty countries worldwide

ROLE DESCRIPTION

As a Documentation Specialist Ophthalmic Liquids you ensure the development and support for the worldwide registration of newly developed ophthalmic liquids and the maintenance of existing product registrations. Certain aqueous and oil based liquids are used during a surgical procedure in the human eye. These liquids are called “Ophthalmic Liquids” and are used more and more frequent during eye surgery. This position is a Research and Development position and reports directly to the Strategic Product Management Director Liquids. This position focuses on the completion of product development documentation such as design development documentation, protocols, (test) reports and standard operating procedures (SOP) in support of regulatory approval of the ophthalmic liquids. The development of these products needs a professional and project type of approach.

The product group “Ophthalmic Liquids” is a successful product group of the portfolio and is a substantial part of the Company’s current and future growth.

RESPONSIBILITIES

- Composing and maintaining the registration file for the newly developed ophthalmic liquids to support the Regulatory Affairs Department with the submission of the file;
- Writing and completing the labelling, IFU, box artwork and documentation related with the packaging of Liquids products;
- Completing and writing product development documents such as design development documentation, protocols, (test) reports and standard operating procedures (SOP) in support of regulatory approval of Ophthalmic Liquids;
- Review and approve product development documents from contract manufacturers and contract test labs;
- Oversee and coordinate the product development documentation related activities of contract manufacturers and contract test laboratories;
- Performs a periodic search for the international requirements of the Authorities and for manufacturers of medical devices and pharmaceuticals within the area of the ophthalmic liquids;
- Maintenance of documentation related to SPMD`s activities, such as samples delivery and test results from laboratories.

REQUIREMENTS

- Background that enables a proper understanding of Chemical structures and processes such as (Bio)Pharmaceutical, chemist or analytical education or equivalent (bio) medical education;
- Experience in writing of formal documents such as product development documents, protocols, reports and Standard Operating Procedures (SOP);
- Experience with regulated environments such as ISO, CE and GMP;
- Experience in collaborating with regulatory authorities, such as the FDA;
- Structured and organized way of working;
- Affinity with working in a life science environment.
- Experience in project-based way of working;
- Communication and interpersonal skills to be able to interact at different levels within the organization and external organizations;
- High degree of autonomy;
- IT literacy, particularly in Word, Excel and PowerPoint, Adobe Acrobat;
- Supportive to the project team, enthusiastic, sociable and team player;
- Good working knowledge of project management activities;
- Good written and verbal communication skills and ability to present and critically discuss data in both internal and external discussions;
- Highly organized, with good analytical capability;
- Ability to prioritize in order to work in a more efficient and productive way;
- Willingness to learn and attitude to problem solving as well as creative mind;

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Pascha Groot.

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SIRE Life Sciences®

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