For our offices in Vienna, Austria, we are looking for a
(Junior) Regulatory Affairs Consultant (m/f/d)Medical Devices
Desired time of entry: Q3 - Q4, 2019
- Lead, organize and support key regulatory projects / tasks and regulatory compliance initiatives
- Support preparation of regulatory submissions, license renewals and registrations for clients and work with international authorities
- Work with the regulatory agencies third-party accreditation bodies
- Organize and maintain regulatory documentation to meet regulatory requirements
- Provide regulatory input to product development projects
- Master degree or equivalent in Regulatory Affairs, Natural Sciences or Engineering and professional experience in the area of Medical Devices Regulatory Affairs or Quality Management for Medical Devices
- At least 2-5 years medical device or regulatory affairs work experience is strongly preferred, graduates with any biomedical related experience e.g. in pharma industries, clinical research or health technology assessment are also welcome.
- EU Medical Device Regulation 2017/745, MDD 93/42 and familiarity with harmonized standards such as EN ISO 13485, EN ISO 14971 or MEDDEV guidelines. Knowledge of the new Medical Device Regulation (EU) 2017/745 and project management skills is an advantage.
- Excellent English (spoken and written) is required, advanced German strongly preferred. Other languages a plus.
- Good written and verbal communication skills
- Ability to be flexible and acceptance to travel
- Eager to learn, attention to detail, proven problem-solving & organizational skills, as well as a collaborative personality
- Working in a dynamic, cooperative and global environment
- Flexible working hours
- Personal and professional growth opportunities
- Possible future international assignments
- Attractive salary, extensive benefits and pension plan
The salary for this position will meet the minimum legal requirements but higher salaries are negotiable based on experience and for the right candidate.
Apply for this position:
Send your application (e-mail or postal) to:
Michor Consulting and Trade Services GmbH
Please include the following information:
Personal data: Your home address, phone number and e-mail address
Resume: Preferably in PDF or WORD format
Letter of motivation
References and certificates