Our company is looking for a Regulatory Affairs Specialist
As a key member of our team, you will play a crucial role in ensuring compliance with regulatory requirements and guiding the global registrations of medical lasers, optical fibers, and related accessories. Your expertise in drafting technical files and non-European submissions will be invaluable in this position.
Key Responsibilities :
* Contribute to international registrations of medical lasers, optical fibers, and related accessories;
* Participate in defining regulatory strategies for assigned projects;
* Prepare documentation and application dossiers;
* Serve as a point of contact with Regulatory Authorities and Regulatory Partners (Distributors, Consultants, etc.);
* Support the review process by responding to reviewers' questions and resolving any gaps;
* Manage and coordinate post-approval activities, such as design changes, product configuration updates, and license archiving;
* Prepare periodic communications to be submitted to international Authorities to maintain registrations;
* Evaluate customer complaints to determine the reportability of events in accordance with specific legal and regulatory requirements;
* Support the digitalization of regulatory processes, contributing to the development of electronic document management systems;
* Assess the regulatory impact of design changes, planning and managing notifications to certification and Regulatory Bodies, and handling potential license amendments;
* Take part in inspections focused on regulatory matters.
Qualifications :
* Degree in scientific disciplines;
* At least 3 years of experience in regulatory affairs, preferably within the medical device industry. Experience with international registrations is highly desirable;
* Fluency in both English and Italian;
* Ability to collaborate effectively within team;
* Strong autonomy in achieving goals and delivering results;
* Enjoy engaging with people from diverse cultural backgrounds;
* Driven by curiosity and passionate about new challenges.
Technical Skills Required :
* Experience in drafting technical files and non-European submissions;
* Knowledge of medical device regulations (MDD, MDR, 21 CFR 803-806-820, 21 CFR Ch. I Subpart J, MDSAP, ISO 13485);
* 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;
* Experience in complaint evaluation and regulatory impact assessment of design changes;
* Track record of direct interactions with Notified Bodies and Competent Authorities;
* Knowledge of the eSTAR method for 510(k) submissions (FDA PreMarket Notification);
* Experience with cleaning, disinfection, sterilization, and reprocessing of medical devices;
* Previous experience with laser technology will be considered a plus.
Is this the right opportunity for you? We are waiting for your application.
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