We are fundamentally altering the cancer treatment landscape by creating a modality that uses the unique biology of each tumor as a means to destroy it. Our ground-breaking approach marries positron emission tomography (PET) – the gold standard for visualizing cancer – with radiotherapy – one of the most effective ways to treat cancer. This combination, biology guiding radiotherapy (BgRT), turns cancer on itself, and finally enables radiotherapy for all stages of cancer, including metastatic disease. Biology guiding radiotherapy offers hope for millions of patients who today, have limited treatment options.
At the center of our bold vision, are passionate, committed team members who align with our culture:
- Bold. We aren’t here to fit in and provide yet another radiotherapy solution; we’re here to change the game.
- Confident. We don’t shy away from the challenge of implementing a breakthrough in cancer care – we tackle it head on from all dimensions.
- Heart. Fueled by our own experiences with cancer, this is personal. It’s driven us to develop solutions that have, until now, seemed impossible.
- Challengers of convention. We don’t let today’s technology be a barrier. We dream big and innovate to make our dreams a reality.
Drives the development, coordination, and maintenance of the Reflexion Medical’s Product Lifecycle Management (PLM) Control and Training systems and assures the flow of information in the form of controlled documents. Establish procedures and work instructions needed to meet the demands of document and training control in a medical device company. Responsible for supporting all the documentation, training and compliance needs for a fast paced and dynamic product focused team.
Key Performance Elements/Essential Functions:
- Review and release Change Orders for all document types while maintaining a standard format and approach compliant with applicable standards and regulations.
- Support documentation issuance, version control, manual and electronic files maintenance, and document status notifications.
- Facilitate the incorporation of quality systems/regulatory requirements in accordance with FDA QSR (21 CFR: Part 820), ISO13485:2003/2016, and all other applicable regulations.
- Maintain all controlled document files including security and disaster recovery controls.
- Review and asses software changes made to PLM system.
- Perform and support document formatting, printing and update document trackers/logs.
- Develop and conduct training regarding controlled document format, content, and usage.
- Drive continuous improvement initiatives to change order and training processes.
- Implement training profiles, maintain training records and submit document records within RefleXion’s electronic training tracking system.
- Develop and maintain a complete and accurate index of all documents.
- Oversee issuance and tracking of lab notebooks.
- Create and maintain monthly metrics and reports.
- Actively participate in department meetings as necessary.
- Maintain and update as needed the standards library.
- Support internal and external audits and inspections.
- Support the development of functionally within the PLM software system in support of NCR/CAPA/SCAR/SCR etc.
- Performs all other duties as assigned.