Documentation Specialist Ophthalmic Liquids - Netherlands
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As a Documentation Specialist Ophthalmic Liquids you ensure the development and support for the worldwide registration of D.O.R.C.’s 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 D.O.R.C. portfolio and is a substantial part of the Company’s current and future growth.
- Composing and maintaining the registration file for D.O.R.C.'s 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 D.O.R.C.’s 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.
- 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;
- Excellent English language skills both verbal and in writing;
- Moderate/Basic Dutch language skills both verbal and in writing are preferred.
A varied position in an organization with a unique product in the ophthalmic world. D.O.R.C. offers a pleasant working environment and excellent primary and secondary conditions, including a 100% reimbursement of pension contributions. The collective labour agreement Metalektro applies.
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. was founded in 1983 and developed through close cooperation with leading surgeons in the world an innovative and high-quality line of ophthalmic surgical instruments and disposables. These are applied within the front and rear segment surgery for the treatment of eye disorders. The products are sold in over 80 countries worldwide through subsidiaries in Germany, France, Austria, Great Britain, Sweden, USA, Brazil, Italy and Dubai and a network of distributors. Within the D.O.R.C. group 450 employees are active with 275 working out of our headquarters in Zuidland (Rotterdam area). There is an informal atmosphere. Individually and in (project) teams we work together on the further growth of our organization. We are working hard but several fun activities are organized leading to a pleasant working atmosphere.
For more information about this position please contact Jolien Meijer (Global Recruitment), tel. no. +0031 181 458 080.
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