Regulatory Affairs Specialist

The purpose of this role is to drive continuous further development of the quality management system. Support and implementation of registrations and authorisations of medical devices worldwide.

Your key responsibilities:

Regulatory Affairs / Authorisation

• Support and implementation of registrations and approvals of medical devices worldwide, especially CE, FDA 510(k), NMPA
• Planning and organisation of the validation of sterile products

Quality management:

• Continuous optimisation of the QMS ISO/EN 13485:2016
• Adjustments with regard to MDR 2017/745
• Development of MDSAP
• Organising and conducting audits
• Market observation of products and preparation of reports (PSUR), change management, test equipment monitoring, etc.
• Monitoring and implementation of laws, standards and regulations

Competencies:

• Good at building relationships internally and externally
• Appreciates and embraces multicultural diversity
• Goal orientated, analytical mindset
• Adaptable, creative, proactive and positive
• Independent, structured and systematic way of working
• High level of teamwork and communication skills
• High sense of responsibility
• Loyal and correct
• Constant willingness to learn and perseverance / resilience
• Ability to deal with criticism and conflict
• Sees himself/herself as a service provider
• Ability to maintain confidentiality

Qualifications:

Essential

• Training as a quality specialist / quality manager or university degree with many years of experience in quality management
• 3 years experience in a similar position preferably in the ophthalmology or medical device industry with capital goods/consumables.
• Knowledge of standards ISO 13485, ISO 14971, ISO 11607, ISO 11135 and 11137
• Experience in international approvals (CE, FDA, NMPA etc.)
• Languages: German and English spoken and written.