Manager Regulatory Affairs

Vor 5 Tagen

Langkampfen T, Österreich TECCON Consulting & Engineering GmbH Vollzeit

Vollzeit |Schaftenau

As part of the Hamburg-based TECCON Group—with over 450 employees in IT, engineering, and business—we develop innovative solutions for renowned clients. Our mission is to recognize and nurture human potential by creating tailored connections between companies and talent. Contribute your expertise to our projects and help shape the future.

Deine Aufgaben
- **Regulatory Contact Management**: Act as the primary point of contact for Notified Bodies and global Health Authorities, leading interactions for stand-alone device registrations and Notified Body Opinion processes.
- ** Global Submission Support**: Deliver high-quality regulatory documentation to support worldwide submissions for both combination products and stand-alone devices.
- ** Audit & Inspection Readiness**: Ensure audit readiness and successful participation in inspections, including certification acquisition and maintenance for stand-alone medical devices.
- ** Regulatory Documentation Ownership**: Write, review, and maintain compliant regulatory documents and responses according to internal SOPs, processes, and systems - ensuring quality, consistency, and timely delivery.
- ** Regulatory Project Leadership**: Lead regulatory activities across the development and manufacturing lifecycle of medical devices, overseeing registration, certification, and audit deliverables and timelines.
- ** Strategic Regulatory Oversight**: Provide strategic leadership on device regulatory planning - identifying key deliverables, aligning them with development milestones, and driving successful dossier integration and authority responses.

Dein Profil
- **Educational Background in Life Sciences or Engineering**: Advanced university degree (Master’s or equivalent) in engineering, life sciences, or healthcare-related fields.
- ** Medical Device Regulatory Experience**: Minimum of 5 years’ industry experience in medical device development or registration, with solid knowledge of MDR 2017/745, 21 CFR 820/4, ISO 13485, and ISO 11608.
- ** Clinical Evaluation Expertise**: Proven experience in generating or reviewing Clinical Evaluation Protocols and Reports for device submissions.
- ** Technical Documentation Skills**: Hands-on experience in preparing technical files for stand-alone devices or contributing to Notified Body Opinions/CTD Modules (e.g., P2.4, P3.5, P7) for combination products.
- ** Strong Communication Skills in English**: Fluent in English (written and spoken), with excellent ability to communicate complex regulatory content clearly and effectively.
- ** Leadership in Cross-Functional Environments**: Demonstrated ability to lead cross-functional teams and drive results in a highly matrixed, global organization.

Deine Benefits
- **Exciting challenges** and **responsible tasks** with plenty of creative freedom and personal responsibility
- ** Long-term career prospects** in a dynamic and dedicated team
- ** Flexible working hours**and **remote work options**to support a healthy work-life balance
- Diverse **development and training opportunities** to help you reach your full potential
- Engaging **team events** that strengthen team spirit and add variety to your work life

The gross annual fulltime salary is at least EUR 80.000 € but of course we offer overpayment in line with the market, depending on qualifications and professional experience.

- Ihre Ansprechpartnerin

Renate Stefanowski
- **TECCON Consulting GmbH**
Am Tabor 36
1020 Wien

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