REGULATORY AFFAIRS SPECIALIST

Quanta System S.p.A.; Samarate; Hybrid; EUR 28,000 - 34,000; Full time

Benefits offered by this job

On-site gym

Hybrid work model (remote up to 2 days

Job summary

Quanta System S.P.A. in Samarate, Italy, is seeking a Regulatory Affairs Specialist to join Regulatory, Clinical & Medical Affairs and support global registrations of medical lasers, optical fibers and related accessories.

You will contribute to regulatory strategies, prepare dossiers, liaise with authorities and partners, and help digitalize regulatory processes while ensuring compliance with MDR/MDD, ISO 13485 and related standards.

Qualifications

• Degree in scientific disciplines.
• At least 2 years in regulatory affairs, preferably within the medical device industry.
• Fluency in English and Italian; ability to collaborate within a team.

Responsibilities

• Contribute to international registrations of medical lasers, optical fibers, and related accessories.
• Define regulatory strategies for assigned projects, working with senior team members.
• Prepare documentation and application dossiers.
• Communicate with Regulatory Authorities and Regulatory Partners (Distributors, Consultants, etc.).
• Assist in responding to reviewers' questions and addressing gaps.
• Support post-approval activities including design changes and license archiving.
• Prepare periodic communications to international Authorities to maintain registrations.
• Assist in digitalization of regulatory processes and electronic document management systems.
• Assess regulatory impact of design changes and notify certification bodies as needed.
• Participate in inspections focused on regulatory matters.

Skills

Fluent English

Fluent Italian

Team collaboration

Curiosity

Intercultural sensitivity

Education

Scientific degree

Tools

Documentation management

eSTAR knowledge

Notified Bodies liaison

Job description

Company QUANTA SYSTEM S.P.A. Location Samarate, Italia Functional Area Regulatory Affairs

Company Description

WHO WE ARE

Quanta System is a 100% Italian company that offers on the global market innovative laser systems for Surgery, Aesthetics and Art Conservation since 1985.

Our main purpose is to increase our positive impact on the world through more than 30.000 installed lasers in 150 countries.

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 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 respect and mutual listening, among people who use creativity to seek out solutions that reflect and enhance each individual’s uniqueness and strengths.

Group Diversity, Equity & Inclusion Policy

Quanta System and the El.En. Group are committed to ensuring a positive, constructive, and dynamic work environment that supports the diversity of individuals and their talents, opinions, and perspectives, guaranteeing equal opportunities for all based on the principles of impartiality. Quanta System and the El.En. Group are dedicated to preventing any form of discrimination.

Position

ABOUT THE ROLE

We are looking for aRegulatory Affairs Specialistto join our team Regulatory, Clinical & Medical Affairsand support global registrations of medical lasers, optical fibers and related accessories.

MAIN RESPONSIBILITIES

As a Regulatory Affairs Specialist, you will support the team in the following activities:

• Contribute to international registrationsof medical lasers, optical fibers, and related accessories;
• Support the definition of regulatory strategiesfor assigned projects, working closely with senior team members;
• Prepare documentation and application dossiers;
• Support communicationswith Regulatory Authorities and Regulatory Partners (Distributors, Consultants, etc.);
• Support the review processby responding to reviewers’ questions and resolving any gaps;
• Support post-approval activities, such as design changes, product configuration updates, and license archiving;
• Prepare periodic communicationsto be submitted to international Authorities to maintain registrations;
• Support the digitalization of regulatory processes, contributing to the development of electronic document management systems;
• Contribute to the assessment of the regulatory impact of design changes, supporting notifications to certification and Regulatory Bodies and potential license amendments;
• Take part in inspectionsfocused on regulatory matters.

Requirements

• Degree in scientific disciplines;
• At least2 years of experiencein 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;
• Enjoy engaging with people from diverse cultural backgrounds;
• Driven by curiosity and passionate about new challenges.

Technical Skills Required:

• Experience or strong exposure totechnical file documentationand non-European submissions;
• Knowledge ofmedical device regulations(MDD, MDR, 21 CFR 803-806-820, 21 CFR Ch. I Subpart J, MDSAP, ISO 13485);
• Familiarity withISO 10993, ISO 14971 standardsand application principles of technical standards such asIEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366;
• Exposure to interactions with Notified Bodies and Competent Authorities will be considered a plus;
• Basic knowledge of the eSTAR method for 510(k) submissions (FDA PreMarket Notification) will be considered a plus;
• Familiarity with cleaning, disinfection, sterilization, and reprocessing of medical devices will be considered a plus.

Other information

What We Offer

• Minimum guaranteed gross annual salary of €31,000
• Access to a corporate wellness area with an on-site gym
• Hybrid working model with the possibility to work remotely up to 2 days per week