Regulatory Compliance Specialist

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!