Manager Regulatory Affairs (m/f/d)

TECCON Consulting GmbH; Schaftenau; Hybrid; EUR 80 000 - 100 000; Vollzeit

Zusammenfassung

A leading consulting firm based in Austria is looking for a Manager Regulatory Affairs (m/f/d) to oversee regulatory processes for medical devices. The ideal candidate will have over 5 years of experience in regulatory affairs and a strong background in life sciences or engineering. This role offers flexible working hours and a competitive salary package. Join us to contribute your expertise and shape the future of medical device regulation.

Leistungen

Creative freedom and personal responsibility

Long-term career prospects

Flexible working hours

Diverse development opportunities

Engaging team events

Qualifikationen

• Minimum of 5 years’ experience in medical device development or registration.
• Proven experience in generating or reviewing Clinical Evaluation Protocols.
• Hands-on experience in preparing technical files for medical devices.

Aufgaben

• Act as primary contact for Notified Bodies and global Health Authorities.
• Deliver high-quality regulatory documentation for worldwide submissions.
• Ensure audit readiness and successful participation in inspections.

Kenntnisse

Regulatory expertise

Leadership

Technical documentation

Communication skills in English

Ausbildung

Advanced university degree in engineering or life sciences

Jobbeschreibung

Overview

Join to apply for the Manager Regulatory Affairs (m/f/d) role at TECCON Consulting GmbH.

Vollzeit | Schaftenau

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

Responsibilities

• 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.

Profile / Qualifications

• 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.

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.