Regulatory Affairs Specialist
MNM Diagnostics is a scientific start-up blazing new trails in personalized medicine. We are combining latest technology, AI, science and medicine to improve outcomes of patients with rare diseases and malignant tumours. We are passionate professionalists.
As a Regulatory Affairs Specialist you will be involved in:
- legal support of development of medical-grade Whole Genome Sequencing assays for oncological diagnostics
- implementing novel AI-driven genetic diagnostic tests into clinical practice
- development of company’s regulatory strategy, focused on medical use of WGS technology
- Interpreting and applying FDA and EU regulations and guidance documents to business practices, evaluating risk and proposing solutions to business challenges based on regulatory strategy
- preparing submissions on relevant regulatory proposals and coordinating advocacy actions
- verifying registration documents in concordance with global legal requirements
- Interfacing with regulatory authorities on regulatory and technical matters
- leading meetings with local and international regulatory authorities
- fostering development of internal QMS documentations
- acquiring and maintaining current knowledge of applicable regulatory requirements, scientific and technical issues relevant to assigned projects
- managing and mentoring junior members of the Regulatory Affairs Team.
- cooperating with other departments of the company.
- Advanced Degree (Master’s or above) in law or in the field of biology, medicine, chemistry or closely related field
- 2+ years of experience in regulatory affairs within the life sciences industry (medical, pharmaceutical, IVD)
- excellent understanding of legal regulation processes in IVD or pharmaceutical field
- adherence to rules and legislations as well as internal procedures
- excellent organization and time management skills
- excellent written and verbal communication skills in English and Polish
- ability to plan and implement the fastest path to commercialization of medical technology
- Industry experience in oncology and/or NGS technology and/or clinical trials
- Experience with medical device regulations: CE-IVD, MDD/MDR, CDx, CAP/CLIA, 510(k)
- interpreting and applying FDA guidance and regulations
- preparing and managing IDE and PMA submissions with genomic data analyses
- Understanding of HIPAA and the importance of patient data privacy
- Stable full-time employment
- Plasticity of working hours (home-office is an option)
- Attractive salary
- Access to internal and external training
- Fascinating career path in an international organization,
- Interesting integrations and business travels
We are a young, ambitious international team. As a start-up, we are accustomed to dynamic changes and constant honing of our skills. Our employees will gain priceless experience in international, friendly environment. We foster innovation and personal growth.
The salary depends on experience and skills of the candidate.
Are You interested in our offer? Send us Your CV and motivation letter to convince us, we’re searching just for You! We are awaiting Your inquiry at email@example.com .
The interview will be held in English. We will contact selected candidates via email.