Regulatory affairs specialist

Alchimia Srl; Ponte San Nicolò; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading medical device manufacturer in Italy is seeking a Regulatory Affairs Specialist to manage technical documentation and compliance with EU regulations. The ideal candidate has 2–3 years of experience in the medical device sector and strong knowledge of MDR. This position offers a hybrid work model and opportunities for professional growth, contributing significantly to key regulatory projects.

Servizi

Hybrid working model

Meal vouchers

Welfare benefits

Opportunities for professional growth

Competenze

• Minimum 2–3 years of experience in Regulatory Affairs within the medical device sector.
• Previous experience with Notified Bodies and technical file submissions.
• Solid knowledge of regulatory documentation practices.

Mansioni

• Prepare and maintain the Technical Documentation and Design Dossiers in compliance with EU MDR.
• Support certification processes and manage non-conformities.
• Collaborate with teams for regulatory documentation improvement.

Conoscenze

Knowledge of MDR 2017 / 745

Strong English skills (written and verbal)

Problem-solving skills

Attention to detail

Knowledge of ISO 13485

Knowledge of ISO 14971

Knowledge of ISO 10993

Formazione

Degree in scientific discipline

Descrizione del lavoro

Alchimia is one of the leading European manufacturers of medical devices for ophthalmic surgery and tissue banks. With our expertise in the fields of chemistry, microbiology, and pharmacology, at Alchimia we have adopted this rule : we design each medical device as if it were intended for ourselves.

Since our foundation in 1993, all our products have been developed in collaboration with opinion leaders and the scientific community before being released to the market. This allows us to offer safe, useful, and effective solutions to improve the daily operations of medical staff and the quality of life of their patients. Our commitment to research makes us a reliable partner, able to provide ongoing training and updated scientific information to our distributors and product users. Thanks to the Alchimia team, we now have a network of over 60 independent distributors across Europe and the world, capable of providing fast local service to all our customers.

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, 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 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.

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.
• Hybrid working model, meal vouchers, and welfare benefits.
• A collaborative team with a strong technical and scientific backbone.

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.

This job posting is open to candidates of all genders, in compliance with applicable laws (L. 903 / 77 and L. 125 / 91).