Junior Regulatory Affairs Specialist

• Assess, prepare, and manage technical documentation to support certification and submission processes in the European Union and U.S.A
• Prepare and manage technical dossiers for submission in other countries according to local regulations and guidance documents
• Cooperate with other departments to the creation and update of technical documentation needed according to country requirements
• Assist external stakeholders in the regulatory process per country requirements
• Maintain and update certifications, registrations, and renewals as required by country regulations and assess regulatory impact of medical device changes with respect to country requirements
• Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect
• Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape
• Assist in internal and external audits and provide regulatory input to optimize company compliance and minimize the possibility of non-compliance findings
• Promote the culture of compliance by proactively interacting with all departments and by provision of trainings
• Cooperate to the development of new activities, adapt to new challenges and opportunities, and take on new duties stemming from the development path of company activities

• Bachelor’s degree in engineering, science or related scientific discipline, or equivalent
• Minimum of 2 years of experience in regulatory affairs roles within the medical devices or healthcare industry
• English proficiency at professional level
• Professional knowledge of Reg. (EU) 2017/745 and Title 21 CFR parts 800-898 and technical standards ISO 13485, ISO 14971
• Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy
• Strong analytical skills with a detail-oriented approach
• Ability to work independently and collaboratively across multifunctional teams
• Highly dynamic and adaptable to a fast-moving and innovative environment

Higher degree/PhD will be an advantage