Requirements: English
Company: Alchimia srl
Region: Ponte San Nicol , Veneto
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, weve 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 companys 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 23 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.
- Hybrid working model, meal vouchers.
- A collaborative team with a strong technical and scientific backbone.
- The employment level and compensation package will be determined based on the selected candidates 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, wed love to hear from you.
Apply now and become part of Alchimias regulatory team!
The position is open to candidates of all genders, in accordance with Legislative Decree 198/2006 and subsequent amendments