Senior Regulatory Affairs Specialist

• Assess medical device safety by providing input/review to the risk management activities throughout the whole product lifecycle, health hazards evaluations, and clinical evaluation reports
• Review and provide input on mitigations, labeling and training materials, adverse events, complaints, incidents, and trends
• Manage and document post-marketing safety data, aggregate complaint data, individual case safety reports, literature reports with safety data, trend analysis
• Manage vigilance reporting to Competent Authorities and other stakeholders according to country requirements and assess failure investigations from the regulatory viewpoint
• Work with customers/users to gather information/data to support investigations and complaints management
• Monitor external sources/trends on emerging issues, including complaints, MDR trends, and regulatory trends, literature and scientific publications
• Transfer the regulatory compliance aspects during the design and development stage of products and act as contact point across the company functional areas
• Act as department representative during audits and other regulatory body interactions in the field of vigilance and post-market surveillance
• 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
• 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 medicine, pharmacology, biomedical science or related scientific discipline, or equivalent
• Minimum of 5 years of experience in the regulatory affairs field in medical device industry
• Minimum of 2 years of experience in vigilance reporting according to 21 CFR Part 803 in U.S and to MDD/MDR requirements in EU
• English proficiency at professional level
• Deep knowledge and operative understanding of Reg. (EU) 2017/745 and MDCG documents, Title 21 CFR parts 800-898, and technical standards such as ISO 13485, ISO 14971, ISO/TR 20416, ISO 62304
• Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy
• Basic knowledge of Reg. (EU) 2024/1689
• 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