Sr Regulatory Affairs Specialist - Medical Devices - Ghent Area

• Regulatory Affairs specialist - Medical devices in Dental care
• Focus on private label for precision accessories in the dental field
• Worldwide coverage

Client Details

Our client is worldwide known company active in the medical devices industry with a major focus on Dental care, with a very successful private label range that offers precision attachments and accessories for dental technicians.

Sales and distribution are organized at the Belgian HQ. From there, shipments to a worldwide distributor network leave every day. These distributors are responsible for local distribution while receiving technical and commercial support from the regulatory team.

In the context of the further expansion of the service of the range, they are looking to strengthen their team with a new Sr Regulatory Affairs Specialist.

In order to ensure that the product Technical Files meet applicable regulatory requirements in order to maintain product and QMS Certification and obtain/maintain the approvals needed to conduct its current and future business activities; produce, sell, and distribute its goods and services.

Description

As the successful Sr Regulatory Affairs Specialist - Medical devices - Dental, you will have the following responsibilities:

• Compilation and maintenance of the technical documentation, and update of databases or systems to ensure ongoing regulatory
  
  
• Compilation and critical review of technical docs such as PSURs/CEPs/CERs
  
  
• Coordination of all efforts associated with the preparation of regulatory documents or submissions., Filing of necessary applications for market entry and handling all regulatory and Notified Body
  
  
• Serving as the Regulatory Affairs representative on internal project teams for new business and for the ongoing regulatory compliance for HS and subsidiary
  
  
• Ensure that the organization's regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations, laws, and
  
  
• Ensure that the organization has the certificates, authorization's, and other approvals it needs to conduct its current and future business activities; to produce, sell, and distribute its goods and
  
  
• Support business leadership and department managers to understand their short to medium-term business goals (for example introducing a new product, service, or operating process or entering a new market) and develop plans, and schedules for acquiring the necessary permits and other
  
  
• Establish and maintain positive relationships with Notified Bodies and internal and external regulatory teams and suppliers; represent the organization in matters before regulatory, legislative, or industry standards agencies so that the organization's interests are
  
  
• Assess potential risks e.g. as part of change control, ensure compliance and give recommendations.
  
  
• Support the hosting of audits and inspections of the organization and its critical suppliers, taking part in any due diligence targets and inspections as
  
  
• Support product labelling reviews and programs of labelling update
  
  
• Support the QMS procedures updates
  
  
• Support trade compliance (import and export) regulatory
  
  
• Assist with marketing practices and data protection
  
  
• Other tasks and projects as needed

Profile

As the successful Sr Regulatory Affairs Specialist - Medical devices - Dental, you will have the following requirements:

• A Bachelor's degree in Regulatory Affairs/Life Sciences or related field preferred - equivalent by experience will be strongly valued as well
  
  
• Experience of at least 2-4 years of Regulatory Affairs and Quality System experience in the medical device industry
  
  
• Exp working within ISO 9001 and ISO 13485 quality management system is a strong asset
  
  
• Use to Compilation and Maintenance of EU Technical Files and documentation

• Demonstrates a thorough knowledge and understanding of the MDD 93/42/EEC and guidelines and MDR 2017/745
  
  
• Awareness of Legal Manufacturer/PL requirements
  
  
• Technical File compilation and maintenance
  
  
• Knowledge on Quality System process implementation and maintenance to meet ISO 13485 requirements and certification
  
  
• Disciplined working methods and strong organizational skill
  
  
• Ability to work in project teams and to provide regulatory guidance at new product introduction stage through to product launch

• Balances a sense of urgency of time pressures with adherence to all regulatory requirements
  
  
• Demonstrates advanced oral and written communication skills in English
  
  

Job Offer

As the successful Sr Regulatory Affairs Specialist - Medical devices - Dental, you will have:

• The chance to join a strong, international and dynamic company with room for further personal development and growth.
• an attractive salary package including all the benefits available (Company car, Net allowances, Insurances, Meal vouchers, etc.)