Regulatory Affairs Manager (m/f/d)

Croma-Pharma; Gemeinde Leobendorf; On-site; EUR 55,000 - 67,000; Full time

Benefits offered by this job

Flexible working hours

Home office

Public transport connections and free/

Meal allowance

Pension and health care

Professional development

Job summary

Croma-Pharma is seeking a Regulatory Affairs Manager for aesthetic medical devices to drive global registrations, including ASEAN and Russia, in a dynamic, international environment. You will plan and implement registrations, assess change notifications, ensure renewals, monitor regulatory requirements within the QMS, and liaise with consultants and distributors to maintain compliant operations.

This role offers flexible hours and strong development opportunities within a growing company based

Qualifications

• Bachelor’s degree and 3–5 years regulatory affairs experience in medical devices.
• Experience preparing and submitting regulatory dossiers and managing global projects.
• Russian language is a plus.

Responsibilities

• Manage regulatory projects for aesthetic medical devices on a global scale (ASEAN, Russia).
• Plan and implement medical devices registrations in these areas and ensure maintenance of registrations.
• Assess change notifications and prepare/submit variations for registrations and renewals.
• Oversee regulatory requirements within the quality management system and ensure compliance.
• Communicate with regulatory consultants and distributors.
• Conduct regulatory intelligence and internal trainings.

Skills

Regulatory affairs

Global project management

Dossier submissions

Russian language

Education

Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field

Job description

CROMA-PHARMA is an internationally active pharmaceutical company with its headquarter in Leobendorf, Korneuburg district, in the north of Vienna. Many years of experience in the manufacturing of products based on hyaluronic acid and a unique level of expertise in the field of aesthetic medicine have made CROMA-PHARMA a globally renowned specialist in the dynamic and versatile business of anti‑aging.

At Croma-Pharma, we are committed to developing and marketing innovative products that help our customers improve their well‑being. Join us and grow with us.

Your future job

• Manage regulatory projects for aesthetic medical devices on a global scale in ASEAN countries and Russia.
• Plan and implement medical devices registrations in these areas and insure maintenance of registrations.
• Assess change notifications and prepare/submit variations to registrations and insure their timely renewal.
• Oversee regulatory requirements in countries and insure compliance within the quality management system.
• Communicate with external stakeholders such as regulatory consultants and Distributors.
• Conduct regulatory intelligence, internal trainings and maintain overviews.

Your Qualifications And Skills

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field (Master’s preferred).
• 3–5 years of regulatory affairs experience in the medical industry, ideally with high risk and substance based devices.
• Proven track record of preparing and submitting regulatory dossiers and managing projects on a global scale.
• Russian language as a plus.

We offer

• Collective agreement for the chemical industry, 38 hours a week - the minimum gross salary according to the KV is EUR 60.977,70 for this position. The actual salary depends on the specific qualification and experience.
• Flexible working hours and home office
• Good public transport connections and free parking spaces
• Croma restaurant with meal allowance and in-house fitness center
• Pension and health care (company doctor and employee assistance programs)
• Professional development