Regulatory Science

1 day ago

Pulong Santa Cruz, Calabarzon, Philippines Ivoclar Vivadent Services & Support, Inc. Full time

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:

  • 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

Continuous Improvement & Collaboration:

  • 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.

What You'll Bring:

  • 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.

What We Provide:

  • 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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