Social network you want to login/join with: Regulatory Compliance Specialist, samarate
col-narrow-left Client:
Quanta System Spa Location:
Job Category:
Other - EU work permit required:
Yes col-narrow-right Job Reference:
478145122793632563233710 Job Views:
4 Posted:
22.08.2025 Expiry Date:
06.10.2025 col-wide Job Description:
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 Compliance Specialist
to join our Regulatory Affairs Team and support activities to
ensure medical devices compliance
with applicable regulatory requirements by drafting user manuals in line with relevant standards and creating up-to-date technical documentation to be submitted to notified bodies and competent authorities. MAIN RESPONSIBILITIES As a
Regulatory Compliance Specialist,
you will contribute to the following core activities: Identify
and
evaluate compliance requirements
for new and existing products or features. Cooperate with cross-functional teams
to ensure compliance during the design development. Assess medical device safety
by providing input/review to the risk management activities throughout the whole product lifecycle, health hazards evaluations. Draft User Manuals
that comply with relevant regulatory requirements and medical device standards, manage and identify translations needs. Create Technical Documentation
up-to-date and compliant with respect to the applicable requirements to be submitted to the Auditing organizations and authorities. Manage the submission of Technical Documentation
to the Notified Bodies by developing necessary materials and addressing queries and possible deficiencies. Evaluate customer complaints
to determine the event reportability according to the local law and regulatory requirements. Collaborate during audits
and other regulatory body interactions for the topics related to Technical Documentation. WHO WE ARE LOOKING FOR To successfully carry out the required activities, we are looking for candidates with: A
Degree in scientific disciplines
or a minimum of
2 years work experience
in product compliance
with specific reference to electromedical devices (Class I, IIa, IIb). Fluency in written and spoken
English
and Italian. Strong writing and editing skills
with the ability to explain complex concepts in a simple and understandable manner. Excellent
project management
and organizational skills. Strong
attention to detail
and a commitment to quality. Ability to work effectively in a cross-functional team environment. Technical Skills Required: Knowledge of EU Regulation 2017/745 (MDR) and Regulation (EU) 2022/2346, technical standard IEC 60601-1 related collateral standard (e.g.: IEC 60601-1- 2; IEC 60601- 1- 6), the standard IEC 60601- 2- 22, and of IEC 60825- 1. Knowledge of the standards ISO 14971 (Risk Management), ISO 10993 series (Biocompatibility), ISO 11135 (Sterilization), ISO 17664 (Reprocessing). Proven experience as a technical writer in the medical device or healthcare industry. Proficiency in using graphics software tools (e.g., Adobe Illustrator). Does this sound like the right opportunity for you? Apply now!
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📌 Regulatory Compliance Specialist
🏢 Altro
📍 Samarate