Regulatory Affairs Professional

5 giorni fa

Roma, Lazio, Italia Cosmoimd A tempo pieno
Job Overview
At Cosmo Intelligent Medical Devices, we are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the compliance of our medical devices with regulatory requirements.

About the Role
We are looking for an experienced professional with a strong background in regulatory affairs, particularly in the medical device industry. Your expertise will play a critical role in maintaining our company's commitment to quality and safety. You will work closely with cross-functional teams to ensure that our products meet all regulatory requirements, from design and development to post-market surveillance.

Main Responsibilities
- Assess medical device safety by providing input/review to risk management activities throughout the 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.

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