Regulatory Affairs

3 settimane fa

Ponte San Nicolò PD, Italia Alchimia srl A tempo pieno

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.
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.

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.

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.
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).
Verify and maintain updated safety data sheets for medical devices.

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.
Excellent command of English , both written and spoken.

Creative thinker , open to innovation and new approaches.
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.

  • Regulatory Affairs

    3 settimane fa

    Ponte San Nicolò (PD), Italia Alchimia srl A tempo pieno

    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. This approach allows us to offer safe, effective, and reliable solutions that...

  • Regulatory Affairs Associate

    3 settimane fa

    Ponte San Nicolò (PD), Italia Alchimia srl A tempo pieno

    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...

  • Regulatory Affairs Associate

    3 settimane fa

    Ponte San Nicolò (PD), Italia Alchimia srl A tempo pieno

    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...

  • Regulatory Affairs Associate

    3 settimane fa

    Ponte San Nicolò (PD), Italia Alchimia srl A tempo pieno

    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...

  • Regulatory Affairs Associate

    2 settimane fa

    Ponte San Nicolò (PD), Italia Alchimia srl A tempo pieno

    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...

  • Regulatory Affairs Specialist

    3 settimane fa

    Ponte San Nicolò (PD), Italia Alchimia srl A tempo pieno

    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...

  • Regulatory Affairs Specialist

    3 settimane fa

    Ponte San Nicolò (PD), Italia Alchimia srl A tempo pieno

    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...

  • Regulatory Affairs Specialist

    7 giorni fa

    Ponte San Nicolò (PD), Italia Alchimia srl A tempo pieno

    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...

  • Regulatory Affairs Associate

    3 settimane fa

    Ponte San Nicolò, Italia Alchimia srl A tempo pieno

    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...

  • Regulatory Affairs Associate

    2 settimane fa

    Ponte San Nicolò, Italia Altro A tempo pieno

    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...