Global Regulatory Affairs Specialist — Medical Lasers

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

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.