Regulatory Affairs Manager
As the Regulatory Affairs Manager, you will be responsible for 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, be involved in marketing authorization submissions in new countries as agreed within the QA and Commercial teams.
Regulatory Affairs Manager
We are currently looking to enlarge our team with a full-time or part-time Regulatory Affairs Manager. This position is also open to freelancers!
As the Regulatory Affairs Manager at radiomics, you will be responsible for 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, be involved in marketing authorization submissions in new countries as agreed within the QA and Commercial teams.
You will be responsible for:
- Act as Radiomics’ Responsible Person in compliance with EU and US medical devices regulation including:
- acting as Radiomics main point of contact with EU and US regulatory agencies;
- ensuring 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.
- Provide Regulatory Affairs support for the commercial team, in compliance with 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
- Ensure regulatory compliance in accordance with all national and European regulations.
- Provide regulatory advice and agree response strategies in relation to Q&A processes related to LCM activities
- Be responsible for RA documentation for on-going clinical trial investigations
- Work in a team environment with collaborations across locations and departments with e.g. regulatory strategies for submissions, pre-submission meetings, scientific advice preparation, including writing and supporting regulatory communications
- Liaise and negotiate with global regulatory authorities as needed for aspects pertaining to LCM including resolution of key regulatory issues to expedite IND/CTA/MAA approvals
- Contribute to internal regulatory policies and procedures to achieve best practices and work processes and if needed writing SOPs
- Support the company through regulatory intelligence efforts in staying abreast of newly issued regulatory laws, guidance and technical publications.
With moderate supervision, 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;
- Act as Radiomics RA main representative for communications with regulatory bodies as appropriate;
- Act as RA representative in new projects;
- Notification to the regional quality and regulatory team for sharing status & update of ongoing projects;
- 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;
- Support local commercial teams related to Quality and Regulatory questions and activities;
- Communicate business related issues or opportunities to next management level;
- Ensure personal and Company compliance with all local and Company 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.
Your educational background and competences:
- BS degree in Engineering, Medicine, Physical or Biological science or similar obtained by experience;
- Minimum of 5 years’ experience in Regulatory roles;
- Experience or interest in RA for Software as Medical Device (SAMD);
- Familiar with EU and US regulatory requirements;
- Willingness to learn in a complex and dynamic environment;
- Must be proficient with MS Office applications;
- Excellent communication skills (verbal and written);
- Project management skills preferred;
- Problem solving skills;
- Presentation skills preferred;
- High degree of initiative;
- At easy in engaging with external Regulatory stakeholders.
Your desired characteristics:
- Strong interest and some knowledge of drug development, digital healthcare, information systems, networking and ICT;
- Hands-on mentality, you work accurately, and you fit into an innovative environment;
- Ambitious, fast learner, passionate, curious and creative;
- Excellent attention to details;
- 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;
- 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;
- Robust interpersonal skills, with demonstrated 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, leading edge, 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.
If you feel challenged by this opportunity and have a team-oriented / self-driven learner mentality, please share your most recent portfolio of past works, CV and cover letter to firstname.lastname@example.org
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.