Our Company
Our people embody being the best, mirroring our product and industry values to be the very best versions of themselves. We essentially have our own language for people power. Self-owned and driven by our incredible world of passionate people.
Sinclair exists to create confidence! Confidence in our products, for our customers and of course, for our people. Our business is on a journey to become the dominant player in strategic global locations, rivalling our competition with diverse product development, by 2026.
Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range (from injectable fillers for the body to medical devices for hair removal, fat sculpting and skin rejuvenation). With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.
Job Overview
The RA/QA-Design Specialist owns the technical file / documentation, maintains up to date technical files and technical documentation history, and keeps all documentation in line with regulatory requirements. Controls suppliers of technical file activities and keeps all documentation in line with all regulatory requirements.
Key Responsibilities

• Responsible for the technical file that supports the safety and efficacy of the product.
• Responsible for the regulatory assessments of changes.
• Maintains an up to date technical file and technical documentation history.
• Designs and writes summaries tor regulatory compliances.
• Provide international regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents).
• Provide general support for external regulatory team and projects, as needed.
• Coordinate the generation and maintenance of product dossiers and all related supporting documentation for product registrations.
• Supply technical documentation and other related information to outsourced suppliers in order to help coordinate and respond to inquiries from regulatory authorities in order to facilitate new registration, design change notifications and license renewal.
• Understand the company’s products, application techniques and use of the implants.
• Present and defend technical documentation during regulatory inspections and internal audits.

In addition, the RA/QA-Design Specialist works closely with the R&D department and can assist in:

• Complaint handling. Root cause investigations.
• Risk assessments. Extensive knowledge input into risk management.
• Project and Change management. Manages a project.
• CAPA management. Root cause investigations and reporting and manages a projects related to the CAPA's.
• Conducts internal audits and inspections when required.

Experience and Qualifications
Essential :

• Bachelor’s Degree or similar experience in medical device or pharmaceutical manufacturing
• Has relevant experience in the medical device or pharma industries.
• Displays creative and original thinking
• Has extensive knowledge of the applicable medical device regulations.
• Should have up to date knowledge on the regulatory requirements, practices and procedures.
• Must possess good technical writing ability
• Strong communication and presentation skills
• Profound understanding of Microsoft Office (Word and Excel).

Desirable :

• Generates suggestions for improving work
• Maintain regulatory compliance
• Maintain technical documentation
• Support with registrations
• Support with changes
• Team player
• Strong communication skills
• Open mindset
• Handles changes as opportunities

Job Competencies
Assures that the technical files are updated and provided with accurate and relevant information. Applies to Global regulatory requirements.
Role competencies:

• Being able to manage the documentation that supports the safety and efficacy of the product.
• Good overall understanding of the global regulatory framework.
• Designing and writing of technical documentation to support the requirements of the different global markets.
• Being able to provide international regulatory support through the product life cycle on product Project teams Please provide bullet points here
• Being able to Coordinate the generation and maintenance of product Dossiers and all related supporting documentation or product registrations.
• Supply technical documentation and other related information to outsourced suppliers in order to help coordinate and respond to inquiries from regulatory authorities in order to facilitate all applications and required changes before the notified bodies.

General competencies:

• Being able to work in a cross sectional team, being a team player and supporting other tasks when possible.
• Being able to communicate effectively and clearly, without hesitation to raise a hand when necessary.
• Critical thinking and problem solving skills.
• Being able to make compelling and delivering presentations
• Management of different kinds of projects

Values and Behaviours
We are a business driven by values and our collaborative culture. We embrace diversity in our global space and under our One Sinclair approach connect in a globally local people-focused world.

• Create confidence
• Transformative innovation
• Passionate
• Agility
• Global collaboration
• Act with integrity
• Be result driven.
• Embrace your Winning spirit.
• Stay ahead of the game.
• One team , One goal

Job Type: Full-time
Experience:

• regulatory requirements, practices and procedures: 3 years (Required)
• CAPA management: 3 years (Required)
• technical writing: 3 years (Required)

Work authorization:

• Netherlands (Required)

Work Location: In person