Regulatory Affairs Associate

Alchimia Srl; Padova; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A leading medical device manufacturer in Padova is seeking a Regulatory Affairs Associate. This role involves managing international product registrations, ensuring compliance with relevant regulations, and maintaining technical documentation. The ideal candidate should have a degree in a scientific discipline and prior experience in Regulatory Affairs. Excellent English communication skills and attention to detail are essential. This position offers a dynamic working environment with opportunities for career growth.

Servizi

Meal vouchers

Welfare programs

Smart working options

Competenze

• Minimum 1 year experience in Regulatory Affairs or related roles in biomedical sectors.
• Knowledge of ISO standards and medical device regulations.
• Excellent command of English, both written and spoken.

Mansioni

• Manage international product registrations and documentation.
• Prepare technical files and ensure compliance with regulations.
• Support inspections by Notified Bodies related to product documentation.

Conoscenze

Regulatory compliance management

Analytical and problem-solving skills

Excellent written and verbal communication

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 chemistry, microbiology, and pharmacology, we have adopted a simple 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 close collaboration with opinion leaders and the scientific community before being released to the market.

This approach allows us to offer safe, effective, and reliable solutions that improve the daily work of healthcare professionals and the quality of life of their patients.

Our ongoing commitment to research makes us a trusted partner, providing continuous training and up-to-date scientific information to our distributors and users.

Thanks to our dedicated team, Alchimia now operates through a network of over 60 independent distributors worldwide, offering fast and reliable local support to customers everywhere.

Position Overview

To strengthen our team, we are looking for a Regulatory Affairs Associate to support regulatory compliance and product registrations worldwide.

The ideal candidate will contribute to maintaining high-quality regulatory documentation and ensuring that Alchimia's medical devices meet all applicable international standards and regulations.

Main Responsibilities

• Manage and support international product registrations by preparing and updating required documentation and communicating with competent authorities.
• Support the definition of regulatory requirements and strategies for technical file submissions in collaboration with cross‑functional teams.
• Assess the impact of product and process changes on regulatory compliance.
• Prepare and update product technical files in accordance with regulatory and normative requirements.
• Maintain up‑to‑date international registration databases.
• Prepare and revise labeling specifications, IFUs, product labels, and post‑market documentation (PMS, PMCFP, PMCFR, PSUR, CEP, CER).
• Keep product and company data aligned with EUDAMED and other relevant international databases.
• Manage reportable events, perform risk assessments, and communicate with authorities (FSN, FSCA).
• Review Design History File (DHF) documentation in collaboration with R&D, QC, and QA departments.
• Perform gap analyses against new standards and regulations, coordinating implementation with relevant departments.
• Support inspections by Notified Bodies and Competent Authorities related to product technical documentation.
• Verify and maintain updated safety data sheets for medical devices.

Qualifications and Experience

• Degree in scientific discipline (preferably Biomedical Engineering, Biology, Chemistry and Pharmaceutical Technologies, Pharmacy, Chemical Engineering, Industrial Chemistry, or Biotechnology).
• Prior experience (minimum 1 year preferred) in Regulatory Affairs or related roles within the biomedical, chemical, or pharmaceutical sectors.
• Knowledge of key standards and regulations: ISO 13485, ISO 14971, ISO 10993, 93/42/EEC, MDR 2017/745, CFR 21 Part 820, CFR 21 Part 211.
• Excellent command of English, both written and spoken.

Key Competencies

• Strong analytical and problem‑solving skills, with great attention to detail.
• Ability to work both independently and collaboratively in a team environment.
• Excellent written and verbal communication skills.
• Strong organizational skills, with the ability to manage multiple tasks and meet deadlines.
• Proactive, positive attitude with a drive for continuous learning and improvement.
• Creative thinker, open to innovation and new approaches.
• Comfortable working in a dynamic environment and adaptable to changing priorities.

What We Offer

• A dynamic and innovative working environment.
• Opportunities for professional development and career growth.
• A supportive and collaborative team culture.
• A competitive benefits package, including meal vouchers, welfare programs, and smart working options.

If you are a highly motivated professional with a passion for regulatory affairs and medical device innovation, we encourage you to apply and join our growing team!

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