Regulatory Affairs Device Manager (m/w/d)
Teccon Consulting and Engineering GmbH
Location
Ebensfeld | Germany
Job description
Regulatory Affairs Device Manager (m/w/d)
Das erwartet dich
- Primary point of contact for Notified Body and global Health Authorities for stand-alone medical device registrations and leadership of Notified Body Opinion interactions
- Deliver high quality regulatory documents to support global Health Authority submissions for combination products and stand-alone devices
- Supports audit readiness activities and medical device inspections including obtainment and maintenance of certification for stand-alone devices
- Write and maintain high-quality regulatory documents and responses for Health Authorities and Notified Bodies according to established guidelines, processes, IT systems and SOPs, to ensure technical congruency and regulatory compliance while meeting agreed timelines and submission requirements
- Regulatory lead for the development / manufacture of medical devices, including management of relevant registration, certification, and audit requirements
- Operational owner of medical device related deliverables and timelines
Das bringst du mit
- University degree in natural sciences, ideally PhD, or comparable qualification
- 3-5 years of Device Regulatory experience
- Knowlegede in Regulatory stakeholder interactions (e.g. Notified Body, EMA, FDA)
- Experience in stand-alone and combination product type medical devices
- Strong communication, negotiation, and interpersonal skills
- Proficient in English (oral and written)
Deine Entscheidung
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 fulltime salary is at least EUR 60.000€ but of course we offer overpayment in line with the market, depending on qualifications and professional experience.
Bei Fragen:
Katharina Morsch
Recruiting Business Partner
[email protected] Einsatzort:
Ebensfeld
Job tags
Salary
