Regulatory Affairs Officer
As the Regulatory Affairs Officer at radiomics, you will be working on the transition of the product from a development project to a marketed product in Life Cycle management (LCM).
Regulatory Affairs Officer
We are currently looking to enlarge our team with a Regulatory Affairs Officer
As the Regulatory Affairs Officer, you will be working on the transition of the product from a development project to a marketed product in Life Cycle management (LCM). In addition, you will be overall RA responsible for the ongoing clinical trials under the supervision of the RA Manager, be involved in marketing authorization submissions in new countries as agreed within the QA and Commercial teams.
You will be responsible for the following:
- Provide Regulatory Affairs support for the commercial team, in compliance with all national, EU and US medical devices applicable regulations and standards to ensure timely commercialization of products;
- Align with all team members to assure timely product development in lead of product / market launch;
- Be responsible for RA documentation for on-going clinical trial investigations under the supervision of the RA manager;
- Maintain current knowledge of relevant regulations, including regulations proposed and already in place;
- Participate in the development or implementation of clinical trial protocols;
- Prepare regulatory agency applications, reports, or correspondence;
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary;
- Support the company through regulatory intelligence efforts in staying abreast of newly issued regulatory laws, guidance and technical publications.
With supervision from the RA Manager, responsible for the following Regulatory activities:
- Develop and implement regulatory strategies and processes to ensure timely commercialization of products in compliance with applicable regulations and standards;
- Support the Radiomics team in contacts with EU and US regulatory agencies;
- Ensure accurate and timely registration of products with both CE and FDA markets;
- Accurate and timely execution of post-market surveillance requirements including complaint handling, vigilance reporting and field actions.
- Notification to the regional quality and regulatory team for sharing status & update of ongoing projects;
- Provide regulatory advice and agree response strategies in relation to Q&A processes related to LCM activities;
- Support local commercial teams related to Quality and Regulatory questions and activities;
- Ensure personal and Company compliance with all local and international regulations, policies, and procedures;
- Ensure RA administrative tasks related to assigned projects are completed as required;
- Support implementation of local Post Market Surveillance measures as required;
- Review local Sales and Marketing material to ensure applicable quality and regulatory requirements are met;
- Monitoring of local Regulatory Environment, and new regulations and support feed-back and gap assessments to International Regulatory Departments and business partners that impact the project;
- Communicate business related issues or opportunities to next management level.
Your educational background and competences:
- BS degree in Engineering, Medicine, Physical or Biological science or similar obtained by experience;
- Minimum of 2 to 3 years’ experience in Regulatory roles;
- Experience or interest in RA for Software as Medical Device (SAMD);
- Familiar with EU and US regulatory requirements;
- Must be proficient with MS Office applications;
- Experience in working in project mode;
- Presentation skills prefered;
- At easy in engaging with external Regulatory stakeholders.
Your desired characteristics:
- Strong interest and some knowledge of drug development, digital healthcare, information systems, and ICT
- Willing to have a strong impact on cancer treatment by helping pharma companies and clinical professionals embrace new biomarkers in their drug development and decision making
- Hands-on mentality, you fit into an innovative environment
- Ambitious, fast learner, passionate, curious and creative
- Excellent attention to details
- Ability to energize, develop, and build rapport at all levels within an organization
- Strong written and verbal communication and clear-thinking skills with the ability to synthesize complex issues into simple messages
- Be pro-active and take initiatives
- Ability to multi-task in a very fast-paced environment
- Solutions oriented and pragmatic
- Ability to work independently as well as effectively collaborate with peers
What we offer you:
- Unique opportunity to help shape a high potential start-up active in a leading-edge AI medical field
- A challenging and diversified position within a high-potential innovative start-up company.
- Huge and fast personal growth potential for the successful candidate
- A young, dynamic, and multicultural environment
- Onboarding, training, and mentorship
- Empowerment, accountability, and recognition
- An attractive salary package, with bonus schemes, in line with the position responsibilities and your experience
Up to the challenge?
If you feel challenged by this opportunity and have a team-oriented / self-driven learner mentality, please send your CV and cover letter to [email protected]
We look forward to welcoming you into this fast-growing Radiomics team!
Founded in 2016, Radiomics is a next generation Liege-based imaging CRO built upon the unparallel experience of its founders, pioneers of the radiomics science. Radiomics uses its proprietary advanced image analysis technology based on AI, deep learning and federated learning to unravel the gold mine of hidden data information embedded in standard medical images with the aim to support insight-based decision making for optimizing pharmaceutical and biotech companies’ clinical trials and drug development studies and for providing clinicians with a patient-centered approach based on personalized medicine.
Based on its non-invasive approach, Radiomics has developed and validated a full pipeline of software as medical device, aimed at disease detection, patient follow-up and treatment prediction. Radiomics first product platform, RadiomiX Toolbox, allows to mine quantitative image features from (standard-of-care) medical imaging. Among other ongoing projects, in 2021 Radiomics will start its first clinical trial, SALMON, aiming at proving the power of radiomics for clinical decision making on oncology compared to current standard-of-care. In addition, Radiomics owns a strong intellectual property portfolio, including rights on the radiomics trademark, and its team is continuously working on new solutions, in collaboration with multiple national and international partners and is currently closing partnerships to scale up its activities geographically and into other disease areas.
Radiomics is ISO 13485 compliant and aims to be ISO 13485: 2016 certified in 2021.