Senior Regulatory Affairs Specialist

Location: Milan, Italy

Position Overview:

As a Senior Regulatory Affairs Specialist (EMEA), you will play a key role in supporting both pre-market and post-market regulatory activities for my medical device client’s product portfolio. You will be responsible for the development and maintenance of technical documentation to achieve MDR CE Certification for selected products, as well as supporting international product registrations within the EMEA and CIS regions. In addition, you will contribute to Post-Market Surveillance and Vigilance activities to ensure compliance with EU regulatory requirements.

Key Responsibilities:

• Oversee and maintain technical documentation for product changes, ensuring compliance with MDR and other relevant regulatory requirements.
• Act as the regulatory expert within cross-functional teams during the development of new products.
• Prepare and submit technical documentation for new product certifications, including MDR CE Marking.
• Support the development and execution of PMS and PMCF deliverables to meet regulatory requirements.
• Assess product complaints for compliance with vigilance reporting requirements and provide necessary documentation to regulatory authorities.
• Support the registration of products in EMEA/CIS regions, ensuring timely submission and approval.
• Stay up-to-date with evolving international medical device regulations and guidance documents.
• Assist in the development and implementation of best practices for regulatory affairs processes and documentation management.

Qualifications:

• Bachelor’s degree in engineering, life sciences, or a related scientific discipline
• At least 3 years of experience in Regulatory Affairs within the medical device industry.
• Strong knowledge of ISO 13485, MDR 2017/745, and other applicable regulatory standards.
• Proven experience in managing technical documentation for medical devices under MDR.
• Experience responding to Notified Body deficiency reports for MDR certification, particularly for both legacy devices and new products, is preferred.
• Experience with international product registrations (EMEA/CIS) is highly desirable.
• Excellent written, verbal, and presentation skills, with the ability to communicate complex regulatory concepts clearly and concisely.