Specialist Post Market Activity
il y a 1 semaine
**Job Information**:
Work Experience
8 years
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
- **Specialist - Post Market Activity.**
**Your role and key responsibilities will be**:
1. Provide professional and smooth external/internal client service at the highest level;
2. 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;
- Managing the medical devices vigilance
- Supervision of field safety corrective actions performed by clients;
- Communication with competent authorities and clients;
- Addressing post market surveillance queries from Competent Authorities
- Managing post market surveillance surveys of clients to ensure compliance with Medical Device Regulation;
- Managing and create performance reports to the board;
3. Contribute to online and offline publications (CEO announcements, internal communication, etc)
4. Provide ah-hoc assistance to the Department Manager;
5. Contribute to the development and design of new methods, systems and resources;
6. Develop and provide internal/external trainings on department related matters.;
7. Contribute to the implementation of ISO 9001 and ISO 13485;
8. Participate in Obelis events;
**Requirements**:
- Preferably a scientific Degree (Bachelor or Master’s Degree in Biomedical Sciences, Vigilance or Pharmacovigilance, Nurse degree, ).
- 7 years experience in Vigilance or 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.
- Be able to and willing to travel in / out of the European Union
**Benefits**:
**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
- Pension plan - assurance de groupe
- 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
- Success driven commission scheme on NEW clients
**About Obelis Group**
Obelis Group is a quality driven, service-oriented company with over 30 years of experience in regulatory affairs. Obelis was founded by Gideon Elkayam back in 1988 vision to create a bridge between non-European manufacturers and the European market by _“creating compliance for safer markets”_. Over the years, the organization has helped over 3,000 manufacturers from more than 70 countries in their compliance journey.
Today, Obelis is the largest center in Europe for CE marking & EU Representative Services, and a proud member of EAAR (The European Association of Authorized Representative) & ERPA (European Cosmetics Responsible Person Association) & EU Commission Working Groups.
**Obelis Culture & Values**
At Obelis, our mission is to create compliance for safer markets and consumers. Our values align to this mission, support our culture, and represent the manifesto of the way we treat each other and our clients and stakeholders.
We believe that every employee creates a difference and makes an impact. This is why, for us, employee satisfaction comes before client satisfaction.
Invest in your career development and find deep meaning and purpose. At Obelis, you will be empowered to achieve more and make an impact on what you are passionate about. your contribution will matter. You will be given autonomy in a diverse workspace with opportunities for growth and great perks and benefits.
- All the reasons to take your next career journey at Obelis:_
- A meaningful work Do meaningful work. Invest in your skills, capabilities & future
- A great place to work Our employees agree, this is a great place to work Hear it from our teams, explore our culture & discover our student & career opportunities
- A career that fits your passion and purpose Join a community guided by values that promote diversity, inclusion and learning.
- An equal opportunity employer We are proud to be an equal employment opportunity. We celebrate diversity
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