- Creating, writing, reviewing, and maintaining high-quality technical documentation (e.g. biological evaluation, clinical evaluation) in compliance with MDR, and other relevant standards (e.g. ISO , ISO 13485)
- Leading the identification, analysis, evaluation, and documentation of product-related risks for medical devices in accordance with ISO 14971, with a strong focus on quality and compliance
- Leading the continuous post-market surveillance (PMS) activities for medical devices class I, IIa and IIb
- Keep up to date with the dynamic regulatory landscape for medical devices.
- Act as a role model by promoting Ivoclar's corporate values of Passion, Vision, and Innovation.
- Master's Degree is a MUST/Higher degree in natural, medical, or technical sciences.
- Experience in writing regulatory documents or a related field beneficial, ideally within the medical device or dental industry.
- Proficient in MS Office and other documentation management tools.
- Strong English communication skills (written and spoken).
- Ability to analyze and interpret complex regulations effectively.
- Reliable, independent, and detail-oriented.
- Strong interpersonal and communication skills.
- Collaborative team player with a solution-oriented mindset.
- Flexible and adaptable to a fast-evolving regulatory environment.
- TRAINING: You will work with various members of our team locally and onshore to ensure you are set up for success.
- SUPPORT: A close-knit coaching and mentoring system to help you ease into the company and into your role with confidence.
- COMP & BEN: Ivoclar believes in compensating employees fairly for their skills and experience and has designed the total rewards package for long-term relationships.
- TOOLS: Everything you need to help you do your work will be provided.
- WORKING ENVIRONMENT: Ivoclar prides itself on being a family-owned company with strong values so everyone we bring in becomes part of that global family.
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+Job summary · Ivoclar seeks Regulatory Affairs Manager - Documentation to ensure regulatory compliance for innovative products. · +ResponsibilitiesCreating technical documentation in compliance with MDR. · Leading risk identification and analysis for medical devices. · ...
Santa Rosa3 linggo ang nakalipas
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Shape the Future of Dentistry with Us At Ivoclar we are dedicated to making people smile – and we want you to be part of it As a Regulatory Affairs Manager - Documentation you will play a pivotal role in ensuring regulatory compliance for our innovative products This is an exciti ...
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Regulatory Science And Technical Documentation Specialist
Para lamang sa mga rehistradong miyembro
Shape the Future of Dentistry with Us At Ivoclar we are dedicated to making people smile – and we want you to be part of it As a Regulatory Affairs Manager - Documentation you will play a pivotal role in ensuring regulatory compliance for our innovative products. · ...
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Regulatory Science - Santa Rosa City - Ivoclar
Paglalarawan
Shape the Future of Dentistry with Us
At Ivoclar, we are dedicated to making people smile – and we want you to be part of it As a Regulatory Affairs Manager - Documentation, you will play a pivotal role in ensuring regulatory compliance for our innovative products. This is an exciting opportunity to collaborate with international teams in product development and contribute to the lifecycle management of medical devices, making a meaningful impact in the dental industry.
Key Responsibilities:
Regulatory Compliance & Product Safety:
Continuous Improvement & Collaboration:
What You'll Bring:
What We Provide:
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Regulatory Science
Para lamang sa mga rehistradong miyembro Santa Rosa
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Regulatory Science
Para lamang sa mga rehistradong miyembro Santa Rosa
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Regulatory Science And Technical Documentation Specialist
Para lamang sa mga rehistradong miyembro Santa Rosa
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Certification Officer
Para lamang sa mga rehistradong miyembro Santa Cruz, Davao del Sur
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Quality Assurance Senior Supervisor
Buong oras Para lamang sa mga rehistradong miyembro Biñan
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r&d specialist
Para lamang sa mga rehistradong miyembro Santa Rosa City
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QA Supervisor
Para lamang sa mga rehistradong miyembro Santa Rosa City
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Regulatory Affairs Officer
Para lamang sa mga rehistradong miyembro Carmona A
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Regulatory Compliance Specialist
Para lamang sa mga rehistradong miyembro Carmona A
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quality assurance staff
Para lamang sa mga rehistradong miyembro Carmona, Metro Manila
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r&d specialist
Para lamang sa mga rehistradong miyembro Santa Rosa
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r&d specialist
Buong oras Para lamang sa mga rehistradong miyembro Santa Rosa
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EHS Officer
Para lamang sa mga rehistradong miyembro Santa Rosa
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Facilities Mechanical Engineer
Para lamang sa mga rehistradong miyembro Cabuyao
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Research and Development/Regulatory Specialist
Para lamang sa mga rehistradong miyembro Cabuyao, Laguna
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Environmental Staff
Para lamang sa mga rehistradong miyembro Cabuyao
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Sr. Facilities Engineer
Para lamang sa mga rehistradong miyembro Carmona, Cavite, Philippines, Philippines
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Manufacturing Plant Intern
InternshipSHIP Para lamang sa mga rehistradong miyembro Carmona
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production supervisor
Para lamang sa mga rehistradong miyembro Cabuyao, Laguna
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Pollution Control Officer
Para lamang sa mga rehistradong miyembro Cabuyao A