Post Market Activity
il y a 1 jour
**Job Information**:
Industry
Health Care
City
Bruxelles
State/Province
Bruxelles-Capitale
Zip/Postal Code
1000
Do you want to contribute to a safe European market while gaining an authentic international experience as a consultant?
Obelis is currently looking for a **Post Market Activity Consultant.**
**Your role and key responsibilities will be**:
Provide professional and smooth external/internal client service at the highest level;
Execute and ensure day-to-day activities associated with the PMA Department at the highest level:
- Processing of all adverse incidents related of medical devices of clients
- Assessing of the seriousness of medical devices incidents
- Ensuring serious incidents are reported to Authorities (medical device vigilance)
- Drafting notification of serious incidents to Authorities
- Communication with clients and Authorities
- Ensuring field safety corrective actions decided by clients are reported and implemented correctly
- Addressing post market surveillance queries from Competent Authorities
- Maintain up to date database on incidents and queries of authorities
- Managing and create performance reports to the board
Contribute to online and offline publications;
Provide ah-hoc assistance to the Department Manager;
Contribute to the development and design of new methods, systems and resources;
Develop and provide internal/external trainings on department related matters.;
Contribute to the implementation of ISO 9001 and ISO 13485;
Participate in Obelis events.
**Requirements**:
- Preferably a scientific Degree (**Nurse degree**, Bachelor or Master’s Degree in Biomedical Sciences, Vigilance or Pharmacological )
- Medical background (e.g.: nurse degree) or in clinical investigation
- Experience in Quality Assurance System is a plus
- Fluency in English (written & oral)
- Proficiency at Microsoft word, Excel, PowerPoint, Outlook
**Benefits**:
We believe that each of our employees has the potential to make a significant contribution. As a result, we take great care when it comes to the satisfaction of our employees. Here is what you can expect:
- Obelis Policy - performance bonus plan, commission scheme, family policy
- Health & wellbeing - sickness days, health insurance, extensive teleworking policy
- Personal development - paid educational leave, funds for personal development
- Commute & travel allowance - commuting allowance & company rental cars
- Extra benefits - mobile subscription, gift vouchers
- Working from home - teleworking from abroad, home office support
- Corporate Social Responsibility - mental health initiatives, wellbeing events and much more
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