**Regulatory Affairs Specialist Position Summary**
This role is designed for a detail-oriented and organized individual who can effectively manage regulatory affairs for medical devices.
The successful candidate will play a crucial part in ensuring compliance with international regulations and maintaining registrations for our company's products.
We are seeking an experienced professional to join our team and contribute to the development of effective regulatory strategies.
Main Responsibilities:
* International Registrations: Contribute to the registration process for medical lasers, optical fibers, and related accessories.
* Regulatory Strategies: Participate in defining regulatory strategies for assigned projects.
* Documentation Preparation: Prepare documentation and application dossiers.
* Regulatory Authority Coordination: Serve as a point of contact with Regulatory Authorities and Regulatory Partners.
* Review Process Support: Support the review process by responding to reviewers' questions and resolving any gaps.
* Post-Approval Activities: Manage and coordinate post-approval activities, such as design changes, product configuration updates, and license archiving.
* Periodic Communications: Prepare periodic communications to be submitted to international Authorities to maintain registrations.
* Customer Complaint Evaluation: Evaluate customer complaints to determine the reportability of events in accordance with specific legal and regulatory requirements.
* Digitalization of Regulatory Processes: Support the digitalization of regulatory processes, contributing to the development of electronic document management systems.
* Regulatory Impact Assessment: Assess the regulatory impact of design changes, planning and managing notifications to certification and Regulatory Bodies, and handling potential license amendments.
Requirements:
* Education: Degree in scientific disciplines.
* Experience: At least 3 years of experience in regulatory affairs, preferably within the medical device industry. Experience with international registrations is highly desirable.
* Languages: Fluency in both English and Italian.
* Skills: Strong autonomy in achieving goals and delivering results, ability to collaborate effectively within team, driven by curiosity, and passionate about new challenges.
Technical Skills Required:
* Technical File Drafting: Experience in drafting technical files and non-European submissions.
* Medical Device Regulations: Knowledge of medical device regulations (MDD, MDR, 21 CFR 803-806-820, 21 CFR Ch. I Subpart J, MDSAP, ISO 13485).
* Standards and Principles: Familiarity with ISO 10993, ISO 14971 standards, and application principles of technical standards such as IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366.
* Complaint Evaluation: Experience in complaint evaluation and regulatory impact assessment of design changes.
* Interactions with Notified Bodies: Track record of direct interactions with Notified Bodies and Competent Authorities.
* eSTAR Method: Knowledge of the eSTAR method for 510(k) submissions (FDA PreMarket Notification).
* Device Reprocessing: Experience with cleaning, disinfection, sterilization, and reprocessing of medical devices.