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QARA Consultant (9 months)
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!
Our client is a professional Medical Devices organization, based in Genf Switzerland.
The company is well-known for their active medical devices, class II.
In this position you will support development projects from design to certification. You will provide guidance how to comply to applicable standards and develop certifications strategy.
Next to this, you will provide compliance and regulations trainings. You will be the interface between the company and testing labs, notify bodies and competent authorities for all product registrations, change notifications and testing.
This position requires an understanding of applicable standards and regulations (ISO 13485, IEC 60601, 21 CFR 820) use as well as certification processes.
This position focuses on subject matter expertise and is not responsible for personnel management.
- Manage compliance to applicable standard processes for products including application and submission to accredited laboratories, reviews of requirements and implementation.
- Manage recognized certification marks processes for products including dossier preparation, submission to accredited agencies, reviews of application and implementation.
- Manage instruction manuals (IFUs) creation and revision including translations, verifications and publishing processes.
- Responsible of the application of the Risk Management process for existing and new products and to insure compliance of the RMF with this process.
- Provide regulatory direction to development project teams as a core team member.
- Develop regulatory strategy for new products.
- Review proposed product changes for impact on regulatory status of the product.
- Interpret and apply MDD, machinery, RoHS EU directives and FDA regulations to business practices and provide regulatory input, advice and guidance to the organization.
- Manage change notification to notify body process, including authoring and publishing electronic submissions.
- Maintain the CE mark Tech File updated in accordance with products specification creation and changes.
- Demonstrate strong writing and communication skills.
- Strong attention to details, and ability to multitask.
- Understand the overall business environment, the orthopaedic industry and the marketplace.
- Mastery of relevant regulations, ability to stay abreast of regulations pertinent to medical devices.
- Ability to function well as a member of the team and build relationship between RA and other areas of the organization.
- Able to identify and assess business risks for a given regulatory strategy.
- Strong computer skills.
- Ability to diplomatically discuss sensitive information with consultants, suppliers, or customers.
- Motivation and commitment to results.
- Ability to apply the Good Manufacturing Practices.
- Present and discuss clinical, design, manufacturing, etc. issues with internal and external personnel (surgeons, distributors, vendors, inspectors, auditors, sales associates, etc.).
Education/ Experience Requirements
- Bachelors Degree (4 year university degree) or equivalent. Degree or background in life sciences, technical (engineering) or related field.
- Regulatory Affairs Certification (U.S. or EU) preferred.
- 4 years prior RA experience. The occupants regulatory background should include the medical device area, and preferably should include orthopaedic experience. Experience in the areas of drug, biologics, and combination products regulations is also desirable.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.