Beschreibung
Overall responsibilities- Ensuring the correct and contemporary message of Field Actions to the competent authorities
- Follw-up and completion messages from Field Actions to the competent authorities
- Central point of contact for the RA and participating countries and internal agencies for assistance to FAs
- Knowledge and analysis of the local regulatory rules and guidelines
- Answering all the questions of the various authorities regarding FA's
- Monitoring of the TG's messages regarding the authorities to FA's
- Knowledge / implementation of country-specific requirements for mandatory reporting of FA's
- Know and follow the guidelines on code of conduct, ethics and compliance programs and other relevant regulations
Responsibilities
- Support / Representation of the manager's FA Performing the process "Field Actions" along with postmarket risk manager
Ideal Background
- Fluent English (oral and written)
- Expirience with medical devices
- In-depth knowledge of the medical device legislation / Vigilance
- Knowledge of the regulatory requirements
EDUCATIONAL REQUIREMENTS:
- Technical Background (Engeneer background nice to have)
- Theory plus 1-2 years of practical experience or
- Higher education without formal education but more experience and add. training Courses
Place of work:
- Switzerland¨
- Office-based, 5-day/week
More Details:
- 8 Months fulltime
- Location: Central Switzerland
- 100% onsite
- Start date: Mai 2013
Please notice: European citizens are preferred
For a confidential discussion about regulatory affairs projects in Switzerland, or to apply, then send your CV to or call me.
I am a specialist recruitment consultant in regulatory affairs for the Pharmaceutical & Biotechnology industry. I offer a number of search options within the industry with a special focus on Switzerland.
If you are a Pharmaceutical professional looking for your next opportunity, then please don't hesitate to get in contact with me. Alternatively if you are currently looking for skilled individuals for the development of your organisation, then I can certainly help.
Your personal contact:
Kristina Bröckel
Regulatory Affairs Consultant
Tel:
mailto:
To find out more about Real please visit www.realstaffing.com