Regulatory Affairs Specialist L.68/99

JR Italy; Venezia; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a dedicated Regulatory Affairs Specialist to join their dynamic team in Venice. This role involves preparing and maintaining technical documentation for medical devices in compliance with EU regulations, particularly MDR. You will actively support certification processes and collaborate with cross-functional teams to ensure regulatory compliance. If you are passionate about making a real impact in the medical device sector and thrive in a collaborative environment, this opportunity offers professional growth and the chance to work on key regulatory projects. Join us in bringing safe and effective products to market!

Servizi

Opportunities for professional growth

Dynamic and innovative work environment

Direct involvement in key regulatory projects

Collaborative team atmosphere

Competenze

• 2-3 years of experience in Regulatory Affairs in the medical device sector.
• Solid knowledge of MDR and ISO standards.
• Strong English skills for documentation and communication.

Mansioni

• Prepare Technical Documentation and Design Dossiers for EU MDR compliance.
• Support certification processes and manage non-conformities.
• Collaborate with R&D and QA teams for regulatory documentation.

Conoscenze

Regulatory Affairs

MDR 2017/745

ISO 13485

ISO 14971

ISO 10993

Technical Documentation

Problem-solving

Attention to Detail

Formazione

Degree in Biomedical Engineering

Degree in Pharmacy

Degree in Biology

Degree in Chemistry

Degree in Biotechnology

Descrizione del lavoro

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Regulatory Affairs Specialist L.68/99, venezia

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EU work permit required:

Yes

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Job Reference:

395238100345605324833711

Job Views:

2

Posted:

02.05.2025

Expiry Date:

16.06.2025

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Job Description:

Regulatory Affairs Specialist

Alchimia is one of the leading European manufacturers of medical devices for ophthalmic surgery and tissue banks. With strong expertise in chemistry, microbiology, and pharmacology, we develop every product with a philosophy of excellence and safety: we design each medical device as if it were intended for ourselves.

Since 1993, we’ve collaborated with opinion leaders and the scientific community to create high-quality, effective, and compliant medical devices that improve the daily work of healthcare professionals and the lives of their patients. With a global distribution network of over 60 partners, we offer reliable and fast local support to customers worldwide.

To support our continuous growth and regulatory strategy, we are looking for a Regulatory Affairs Specialist with strong expertise in MDR and technical documentation preparation.

Main Responsibilities

• Prepare and maintain the Technical Documentation (TD) and Design Dossiers in compliance with EU MDR 2017/745, especially for Class III, IIa and IIb devices.
• Actively support certification processes with Notified Bodies, managing non-conformities, deficiencies, and corrective/preventive actions (CAPA).
• Collaborate with internal teams (R&D, QA, QC) for the creation, review, and continuous improvement of regulatory documentation.
• Evaluate regulatory impact of product and process changes, according to MDR art.120, ensuring timely updates of the documentation.
• Conduct regulatory gap analyses against evolving MDR and applicable ISO standards.
• Prepare and maintain documents including, risk management documentation, product risk assessment, hazard analysis,PMS, PMCFP, PMCFR, PSUR, CEP, CER.
• Support and participate in audits and inspections by Notified Bodies and Competent Authorities.
• Monitor changes in EU and international regulations and assess their impact on the company’s portfolio conducting gap assessment.
• Assist in drafting and reviewing Instructions for Use (IFU), labeling, and safety data sheets.

Requirements & Experience

• Degree in a scientific discipline (e.g., Biomedical Engineering, Pharmacy, Biology, Chemistry, Biotechnology, Chemical ).
• Minimum 2–3 years of experience in Regulatory Affairs within the medical device sector, ideally focused on MDR regulation.
• Solid knowledge of:
• MDR 2017/745
• ISO 13485, ISO 14971, ISO 10993
• Previous experience with Notified Bodies, technical file submissions, and responses to non-conformities or audit findings.
• Strong English skills (written and verbal) – essential for documentation and communication with regulatory bodies.

Ideal Candidate Profile

• Strong problem-solving and critical thinking skills.
• High attention to detail and structured approach to documentation.
• Proactive attitude and a passion for regulatory compliance.
• Comfortable working autonomously as well as within cross-functional teams.
• Ability to handle pressure and manage multiple priorities effectively.
• Curious, resourceful, and constantly updated on regulatory trends and best practices.
• Priority will be given to candidates belonging to the L. 68/99 categories

What We Offer

• A dynamic, innovative, and growing work environment.
• Direct involvement in key regulatory projects and strategic certifications.
• Opportunities for professional growth and regulatory specialization.
• A collaborative team with a strong technical and scientific backbone.
• The employment level and compensation package will be determined based on the selected candidate’s experience and skill set.

If you are passionate about medical device regulation and want to make a real impact in bringing safe, effective, and compliant products to market, we’d love to hear from you.

Apply now and become part of Alchimia’s regulatory team!

The position is open to candidates of all genders, in accordance with Legislative Decree 198/2006 and subsequent amendments