The position holder is supporting EU Head of Regulatory in administrative tasks in regards of Regulatory projects, Quality Management System and Corrective and Preventive actions.
JOB DUTIES & RESPONSIBILITIES:
The position holder is responsible for:
- Managing projects and activities to further improve products and processes from a regulatory point of view.
- Coordinating activities with relevant departments to ensure compliance with applicable regulatory requirements in Europe, the UK and Switzerland.
- Implementing quality system elements focused on regulatory compliance with MDR 2017/745 and ISO 13485.
- Prepare regulatory documentation for PDP, VAVE and production activities and guide the team where necessary.
- Managing the CAPA system (Corrective Action Preventive Action) in collaboration with internal and external process owners to ensure that appropriate corrective and preventive actions are implemented.
- Tracking recalls and FSCA till closure.
- Monitoring regulatory requirements and informing the respective stakeholders for the initiation of preventive measures.
- Attend UFMEA and other risk assessment activities
- Works with Quality Director to ensure documentation is appropriate, complete and in compliance with all regulation.
- Aids in liability claim investigation and document collection.
SKILLS, KNOWLEDGE AND EXPERIENCE:
- Minimum 2 years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
- Ability to read and comprehend (in English and in German) simple and complex instructions, short correspondence, and memos. Documents may include: government regulations, certificates, product manuals, policies and procedures, etc.
- Strong communication and organisational skills
- Computer proficiency with expertise in Microsoft Office applications, spreadsheets, data trending and charting programs required.
- Preferably knowledge of government Portal and B2B systems.
- The ability to exercise good judgement within generally defined practices and policies.
- Ability to solve problems in a practical manner. Needs to have an ability to prioritise; manage multiple tasks; and work productively with all associates and customers.
- The ability to work with no day-to-day supervision or instructions on routine work and only general instructions on new assignments is required.
- Detail oriented with the ability to manage to strict time-lines for reporting and communication
- Strong work ethic and attention to detail is required