Requirements: English
Company: Quanta System Spa
Region: Samarate , Lombardy
WHO WE ARE
As a laser technology company , we innovate to improve life quality of people with one consistent belief: creating new perspectives for future generations by evolving with our most inner attitudes.
Cause there is always a way to make life better. And this way finds its answers in our daily actions.
Our primary goal is to increase our positive impact on the world through more than 30.000 installed lasers in 150 countries.
Our company is constantly growing, in constant evolution not only in the search for innovation but above all for People and Talents who join our path.
We believe in sustainability, in responsibility; we are firm supporters of interpersonal relationships based on mutual listening, between people who know how to leverage creativity in search of solutions.
ABOUT THE ROLE
We are looking for a Regulatory Affairs Specialist to join our team and support global registrations of medical lasers, optical fibers and related accessories.
MAIN RESPONSIBILITIES
As a Regulatory Affairs Specialist, you will play a key role in the following activities:
- 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.
WHO WE ARE LOOKING FOR
To successfully carry out the required activities, we are looking for candidates with:
- 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.
Does this sound like the right opportunity for you? Apply now!