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Quality & Regulatory Affairs Specialist (m/w/d)
Merz Aesthetics Austria GmbH —Wien, W
Wir von Merz Aesthetics sind Teil der Merz-Gruppe und haben unsere EMEA-Zentrale in Frankfurt am Main. Unser globales Headquarter befindet sich in Raleigh,…
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Regulatory Affairs Professional (m/f/d) Medical Devices

Siemens Healthineers -
Wien, W

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Details zur Stelle

Festanstellung | Vollzeit
vor 5 Tagen

Vollständige Stellenbeschreibung

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Regulatory Affairs Professional (m/f/d) Medical Devices

Location: Hybrid Role in one of our offices: Budapest, Vienna, Warsaw

Join our Regulatory Affairs team and help ensure the successful market access and compliance of our products across Austria and selected CEECA markets. In this role, you will work closely with internal and external stakeholders to navigate regulatory requirements and support key business activities.

Your Responsibilities:

Coordinate product registrations and registration updates with distributors, consultants, and business partners.
Collect, review, and manage regulatory documentation required for market access, import, and distribution.
Monitor changes in local regulatory requirements and assess their business impact.
Support certifications, licenses, notifications, and other regulatory activities.
Collaborate closely with business lines, external partners, and authorities on regulatory matters.
Maintain accurate documentation, project tracking, and regulatory records.
Support post-market surveillance, post-market control activities, regulatory audits, and inspections to ensure ongoing compliance with applicable requirements.
Contribute to PCN assessments and support the development, implementation, and continuous improvement of regulatory SOPs, work instructions, and internal processes.

Your Profile:

Experience in Regulatory Affairs within the Medical Device, In Vitro Diagnostic (IVD), Pharmaceutical, or another highly regulated industry.
Knowledge of EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is considered a strong advantage.
Strong attention to detail and a structured approach to managing documentation, compliance requirements, and regulatory processes.
Ability to effectively prioritize multiple tasks and meet deadlines in a fast-paced and dynamic environment.
Excellent analytical, critical-thinking, and problem-solving skills.
Strong interpersonal and communication skills, with the ability to collaborate effectively with both internal and external stakeholders.
Professional working proficiency in English and German.

What else do I need to know?

According to the EU Pay Transparency Directive, we are required to disclose salary information for certain countries.

For candidates applying from Austria, the minimum gross annual salary for this position is EUR 50,000.00. Depending on qualifications and professional experience, a higher salary may be offered.

Who we are:

We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Check our Careers Site at https://www.siemens-healthineers.com/de/career

As an equal opportunity employer, we welcome applications from individuals with disabilities.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. Please create a profile within our talent community and subscribe to personalized job alerts that will keep you posted about new opportunities.

To all recruitment agencies: Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.

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regulatory affairs Jobs in wien w

Regulatory Affairs Professional (m/f/d) Medical Devices

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