Regulatory Affairs Officer Liquids - Netherlands
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- One of our company’s major product groups consists of liquid products that are used by eye surgeons worldwide to perform eye surgery.
- The Regulatory Affairs Officer Liquids supports the projects for our company’s liquid products through guiding the project team to generate the required documentation.
- You perform the review and approval of all documentation that is needed to allow for the liquid products to be marketed worldwide.
- You ensure that these products receive a timely approval from the applicable regulatory authorities based on the current regulatory requirements.
- You continuously anticipate on applicable standards and legislation such that these products can be manufactured according to the applicable standards and legislation and can be marketed worldwide.
- Hierarchically you report to the QA/RA Director and functionally to the Strategic Product Management Director Liquids and you work closely together with the Project Manager Liquids.
- Responsible for giving advice, performing the review and approval of the project plans for new liquid products or changes to existing liquid products;
- Ensures that all project documentation is delivered according to the applicable law and legislation for medical devices and pharmaceutical product;
- Is also responsible for timely execution of the advice, review and approval tasks;
- Supports the project manager liquids in generating the project planning and reports periodically on progress of the assigned tasks;
- Evaluates which registration and quality system requirements there are per specific country and region;
- Keeps contact with the applicable regulatory authorities and or distributors in case of ongoing registrations;
- Analyze and anticipate on applicable medical and pharmaceutical standards and requirements such that the supplied products are conforming to the applicable (inter)national requirements (for instance: 510(k), PMA, establishment and product listings, etc.).
- Bachelor or University degree in Biotechnology, (bio)pharmacy, chemistry or chemical technology;
- Experience with international medical/pharmaceutical law and legislation;
- 3-5 years relevant experience in a multidisciplinary project team in a production environment;
- Excellent English language skills both verbal and in writing;
- Knowledge ofthe EU medical device directive and pharmaceutical law and legislation;
- Solid knowledge on the requirements for sterilization practices, bio compatibility and clinical evaluations.
We offer a challenging position in a fast growing organization with unique products within ophthalmology, a pleasant work environment and excellent compensation and benefits.
- Our company 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 our company 450 employees are active with 275 works from our headquarters.
- There is an informal atmosphere. Individually and in (project) teams work together on the further growth of the organization.
- We are working hard but lots of fun activities are organized leading to a pleasant working atmosphere.