Manager Regulatory Affairs

Vor 3 Tagen

Schaftenau Tyrol, Österreich TECCON Consulting GmbH Vollzeit € 80.000 - € 120.000 pro Jahr

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.

Deine Aufgaben

  • Regulatory Leadership: Act as the primary point of contact for Notified Bodies and global Health Authorities, leading interactions for stand-alone device registrations and Notified Body Opinions.
  • Submission Excellence: Deliver high-quality regulatory documents to support global submissions for combination products and stand-alone medical devices.
  • Audit & Inspection Readiness: Drive audit preparedness and actively support medical device inspections, ensuring obtainment and maintenance of device certifications.
  • Regulatory Documentation: Write, review, and maintain high-quality regulatory documents and responses in line with global guidelines, IT systems, SOPs, and submission requirements.
  • Device Development Support: Serve as regulatory lead throughout medical device development and manufacturing, managing registrations, certifications, and audits while owning timelines and deliverables.
  • Strategic Oversight: Provide strategic direction for device regulatory activities by identifying key deliverables, ensuring timely completion, integrating inputs into dossiers, and leading responses to Health Authority questions and deficiency letters.

Dein Profil

  • Educational Background: Hold an advanced university degree (Master's or equivalent) in engineering, life sciences, or healthcare.
  • Industry Experience: Bring 5+ years of experience in medical device development or registration with strong knowledge of MDR 2017/745, 21 CFR 820 / 21 CFR 4, ISO 13485, and ISO 11608.
  • Clinical Evaluation Expertise: Demonstrated experience in preparing or reviewing Clinical Evaluation Protocols and Reports for medical device submissions.
  • Technical File & Dossier Preparation: Proven track record in generating technical files for stand-alone devices or Notified Body Opinions, including CTD modules (e.g., Module 3 sections P2.4, P3.5, P7) for combination products.
  • Communication Skills: Fluent in English (oral and written), with excellent ability to communicate complex information clearly and persuasively.
  • Leadership in Matrixed Environments: Strong capability to lead cross-functional teams and drive results in complex, highly matrixed organizations.

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 € but of course we offer overpayment in line with the market, depending on qualifications and professional experience.

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