12 beste Stellen als regulatory in tirol – aktuell auf Personalsuche

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TECCON Consulting & Engineering GmbH —Langkampfen, T
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Provide QA expertise and guidance to ensure compliance with requirement of the quality system are met, including implementation of quality risk-based and GxP…

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regulatory jobs near tirol

Risk Management & Design Control Specialist (m/f/d) Medical Devices

TECCON Consulting & Engineering GmbH
Kufstein, T

Jetzt bewerben

Details zur Stelle

Vollzeit

Qualifikationen

Master

Vollständige Stellenbeschreibung

Vollzeit | Kufstein

Are you an expert in your field, ready to apply your know-how to exciting projects?

Join the Hamburger TECCON Group, a team of over 450 professionals specializing in IT, engineering, and business. We develop innovative solutions for prestigious clients, aiming to discover and nurture human potential by creating tailored connections between companies and talents. Bring your expertise to our projects and actively shape the future.

Deine Aufgaben

Risk Management (ISO 14971): Collect and structure input from cross-functional teams and apply the risk management process to compile complete and compliant documentation for the DHF and DMR.
Design Verification & Process Control: Support the definition of design verification and process control activities and provide recommendations on device-related risks and design decisions.
Scientific Documentation: Write clear and scientifically robust documents for external partners, regulatory submissions, and interactions with Health Authorities.
Technical Guidance & Knowledge Sharing: Offer scientific and technical guidance and actively foster knowledge exchange within and across teams.
Project Planning & Coordination: Develop detailed project plans and timelines together with your manager and align these with the cross-functional development team.

Dein Profil

Minimum Requirements:

Educational Background – Engineering Degree: You hold a Master's degree in Engineering or a related field (Medical Engineering, Mechanical Engineering, Process Engineering, Electrical Engineering, Computer Science, or similar) or have equivalent professional experience.
Language Skills – English: You have excellent written and spoken English; German skills are a plus.

Preferred Requirements:

Industry Experience – Medical Devices / Pharmaceutical: You ideally have prior experience in medical device development or the pharmaceutical industry.
Risk Management – FMEA & ISO 14971: You are familiar with risk management methods such as FMEA and standards like ISO 14971.
Software Skills – Polarion: You have experience using Polarion or similar tools for project and requirements management.

Deine Benefits

Exciting, self-organized and responsible tasks
Long-term employment relationship, pleasant working atmosphere in a young, dedicated team
Flexi time agreement, flexible working time model, work-life balance
Opportunities for specialization and subject-specific further education and training
Extremely collegial team with a friendly approach
Various development opportunities within the TECCON Group

The gross annual salary is at least EUR 73.000 but of course we offer overpayment in line with the market, depending on qualifications and professional experience.

Ihre Ansprechpartnerin

Raquel Taylor
Recruiting

[email protected]

TECCON Consulting GmbH
Am Tabor 36
1020 Wien

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Erweiterte Suche

regulatory Jobs in tirol

Risk Management & Design Control Specialist (m/f/d) Medical Devices

R&D Quality Lead

Head of Finance SWARCO ITS Division (m/f/d)

Privacy & Compliance Manager (MarTech)*

Quality & Compliance Specialist (m/w/d)

Senior Expert Engineering Device Development

Associate Director Engineering (m/f/d)

Engineer Parenteral Packaging Development (m/f/d)

Polarion ALM Engineer with Java Skills I Test Management, Automation & Compliance (m/f/d)

Legal Counsel – Corporate Governance & Capital Markets (m/f/d)

Werkstudent (m/w/d) Wirtschaftsrecht

Projektmanager Information Security & Regulatory Compliance (m/w/d)

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