Third Line Support Manager
- Credendo
- Brussels
- Permanent
-
Benefits- Group insurance
- Meal vouchers
- Smartphone
- Laptop
- Individual hospital insurance
- Family hospital insurance
- Disability insurance
- Dental insurance
- Public transport contribution
- Bicycle allowance
- Eco Cheque
- Training
- Benefits plan
- Additional family benefits
- Performance bonus
- Holiday pay
- Additional paid leave
- Remote work
- Furlough leave
- You will use your industry expertise and management capabilities to assure fluent and efficient...
- You will be the lead manager and key contact in technical and complex roll-outs related to Azure,...
Regulatory Affairs Specialist - Medical Devices - Brussels
- Michael Page
- Brussels
- Permanent
- Supports the organization to ensure an adequate and effective quality management system, supports...
- Maintain regulatory affairs files (e.g., registrations and CE-certificates, quality certificates,...
Project Manager - ESG - Agro Industry
- Michael Page
- Brussels
- Permanent
- ESG Strategy Development and Implementation:
- Develop and execute ESG strategies, policies and initiatives that align with the company's overall...
Project Manager
- Robert Half
- Brussels
- Interim
The main responsibilities for this job include: * Take ownership of project schedules and deadlines, keeping everyone on schedule, and communicating...
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Regulatory Affairs Specialist - Medical Devices - Brussels
* RA Specialist - Regulatory Compliance - EU MDR * Based in Brussels - EMEA Scope
Our client is a global market leader is the field of medical devices.
Their EMEA HQ based in Brussels is looking to extend their team and sustain their growth within the Regulatory Affairs department.
Their EMEA HQ based in Brussels is looking to extend their team and sustain their growth within the Regulatory Affairs department.
Regulatory Affairs Specialist - Medical Devices - Brussels
Job description
As the successful Regulatory Affairs Specialist - Medtech, you will have the following responsibilities:
- Supports the organization to ensure an adequate and effective quality management system, supports the quality policy and sustains a quality culture.
- Maintain regulatory affairs files (e.g., registrations and CE-certificates, quality certificates, and device/facility licenses) and distribute information as required to support key stake-holders.
- Maintain an organized overview of applicable market authorizations and licences in the RA database.
- Develop and execute submission strategies to obtain clearance of international product registations in line with the applicable regulations.
- Ensure documentation meets EU MDR and other applicable regultions requirements to allow correct CE-certifications.
- Support and participate in audits performed by internal and external bodies.
- Support international sales and marketing with identification of regulatory registration requirements.
- Monitor regulatory developments and interpretation in EU by linking into available network through MedTech EU, EC commission resources, NB resources etc.
- Actively engage in development and implementation of regulatory projects.
- Follow-up, track and assemble regulatory commitments to Regulatory Agencies as required.
- Act as key interface and represent Avanos with local regulatory authorities and CE-certification agencies.
- Assist in preparation and execution of Field Action activities.
- Assist in the resolution of Quality Notifications and CAPAs as required.
Profile
As the successful Regulatory Affairs Specialist - Medtech, you will have the following requirements:
- Minimum of 3 years of experience within Healthcare environment.
- University degree or related diploma.
- Experience with Excel, Word, PowerPoint and Outlook is required.
- Fluent in English.
- At least 3-5 years experience in Quality and/or Regulatory Affairs.
- RAC certification is a plus
- Ability to manage communication with regulatory authorities with a high level of professionalism
- Strong interpersonal skills and a positive attitude.
- Sound analytical skills (good attention to detail).
- Drive, energy and enthusiasm for meeting and exceeding expectations.
- Hands-on in a fast moving environment and able to work with little supervision.
Offer
As the successful Regulatory Affairs Specialist - Medtech, you will have:
- An attractive salary package - with all extra legal advantages (Insurances, Bonus, Net allowances, Meal Vouchers, etc.)
- Join a market leader - where people thrive to grow and learn
- Join a dynamic and fast growing team with growing responsibilities at the center of the business
Practical information
Michael Page Belgium
Charles Jean
Show number
Bastion Tower
Marsveldplein 5
Place du Champ de Mars 5
1050 Brussels
Charles Jean
Show number
Bastion Tower
Marsveldplein 5
Place du Champ de Mars 5
1050 Brussels
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