Global Regulatory Affairs Manager – Medical Devices (Hybrid)

Croma-Pharma GmbH; Gemeinde Leobendorf; Hybrid; EUR 55.000 - 67.000; Vollzeit

Benefits dieser Stelle

Flexible working hours and home office

Good public transport connections and

Croma restaurant with meal allowance

Pension and health care

Professional development

Zusammenfassung

CROMA-PHARMA is an internationally active pharmaceutical company with headquarters in Leobendorf, Austria. We seek a Regulatory Affairs Manager to oversee global regulatory projects for aesthetic medical devices, plan registrations, and maintain registrations across regions.

Based in Leobendorf with hybrid work, you bring 3–5 years of regulatory experience in the medical industry, a Life Sciences degree, and a proven dossier submission track record.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory affairs

Project management

Dossier submission

Russian language

Ausbildung

Bachelor's degree in Life Sciences / related field

Jobbeschreibung

CROMA-PHARMA is an internationally active pharmaceutical company with headquarters in Leobendorf, Austria. We seek a Regulatory Affairs Manager to oversee global regulatory projects for aesthetic medical devices, plan registrations, and maintain registrations across regions.

Based in Leobendorf with hybrid work, you bring 3–5 years of regulatory experience in the medical industry, a Life Sciences degree, and a proven dossier submission track record.