Senior Regulatory Affairs Specialist

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Within Henry Schein Belgium we have a successful Private Label CEKA PRECI-LINE range that offers precision attachments and accessories for dental technicians. Sales and distribution are organized at Waregem, Belgium. 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 CEKA PRECI-LINE.

In the context of the further expansion of the service of the CEKA PRECI-LINE range, we wish to strengthen our team with a:

Senior Regulatory Affairs Specialist

A Senior Regulatory Affairs Specialist is responsible 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.

YOUR ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Compilation and maintenance of the technical documentation, and update of databases or systems to ensure ongoing regulatory compliance.
• 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 interactions.
• Serving as the Regulatory Affairs representative on internal project teams for new business and for the ongoing regulatory compliance for HS and subsidiary product.
• Ensure that the organization’s regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards.
• 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 services.
• 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 approvals.
• 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 advanced.
• 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 needed.
• Support product labelling reviews and programs of labelling update projects.
• Support the QMS procedures updates
• Support trade compliance (import and export) regulatory requirements.
• Assist with marketing practices and data protection compliance.
• Other tasks and projects as needed.

Physical Activities:

• Job holder based at Waregem, Mannebeekstraat 33
• Occasional travel to conduct supplier assessments

YOUR QUALIFICATIONS:
Experience:

• 2-4 years of Regulatory Affairs and Quality System experience in the medical device industry
• Clinical competency desired
• Compliance/working within ISO 9001 and ISO 13485 quality management system
• Compilation and Maintenance of EU Technical Files and documentation
• Communicating with Regulatory Bodies

Education:

• Bachelor’s degree in Regulatory Affairs/Life Sciences or related field preferred

Specialized Knowledge and Skills:

• 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
• Good oral and written communication skills in English
• Ability to work in project teams and to provide regulatory guidance at new product introduction stage through to product launch

Other:

• Balances a sense of urgency of time pressures with adherence to all regulatory requirements
• Demonstrates advanced oral and written communication skills in English
• Has an eye for details and is stress resistant.

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OUR OFFER:

We offer you the chance to join a strong, international and dynamic company with room for further personal development and growth. We offer an attractive salary package including benefits.

Job Types: Full-time, Permanent

Schedule:

• Monday to Friday