Regulatory Affairs Associate

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).