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Regulatory Affairs Manager
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.
Our client is a growing BioTech company
- Planning, co-ordination, preparation and interpretation of information necessary for product licence applications and registrations for regulatory submissions
- Advise staff and project team members on data and information required for successful license applications
- Compile product information for preparation of tech files and regulatory dossiers to support product licence applications.
- Ensuring that changes are documented in accordance with corporate quality system requirements and are communicated as appropriate to the Regulatory Authorities Conduct all duties in compliance with:
- Good Manufacturing Practice (GMP)
- Good Documentation Practice (GDP)
- Manage analytical data from laboratory processes, clinical field trials and product evaluation data to ensure appropriate review to support regulatory requirements
- Actively participate in product development projects on a regular basis in order to provide guidance on regulatory requirements and to provide supporting regulatory documentation
- Liaise with regulatory agencies and external contract bodies and, in response to requests from these, to collate and interpret specialised information
- Provide advice on the licensing and registration options/regulatory requirements for Biodiagnostics to facilitate process/product development and modifications
- Assist with the implementation of the Companies Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP),
- ISO 9001/ ISO13485 standards,
- the 98/79/EC IVD Directive,
- FDA Regulations,
- Health Canada Medical Device Regulation, Part 1,
- Good Clinical Practice (GCP) and
- approved Health and Safety Policies.
- Contribute to the design and implementation of new quality systems and procedures and identify areas for potential improvement to ensure the concept of continuous quality improvement is realised.
- Schedule routine work within the department in order to maximise the use of available resource.
- Minimum 3 years experience in regulatory affairs
- Regulatory Affairs Professional Society certification or advanced degree in regulatory affairs.
- Previous experience filing BLA, PMA, 510(k)
- Previous experience in bringing a diagnostic instrument to market and or test kit associated with an instrument.
- Experience of working within an FDA licensed manufacturing facility.
- Experience in Medical device (class III) ISO 13485 or IVD a must
- Experience with FDA regulations
- Experience with 510K FDA submissions
- Fluent in English
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.