Regulatory Affairs Manager At Ivoclar, we are dedicated to making people smile – and we want you to be part of it! As a Regulatory Affairs Manager, you will play a pivotal role in ensuring global regulatory compliance for our innovative products. This is an exciting opportunity to collaborate with international teams and contribute to the lifecycle management of medical devices, making a meaningful impact in the dental industry. Key Responsibilities: Regulatory Compliance & Product Safety: Review, research, and update product documentation to ensure compliance with MDR, ISO standards, and global regulations. Participate in risk management, biocompatibility assessments, clinical safety, and post-market surveillance (PMS) processes. Documentation & Coordination: Prepare and review communication documents for strategy rollouts across the Product Lifecycle Management (PLM) landscape. Support international registration activities by preparing global registration dossiers. Collaborate with cross-functional teams to develop and enhance regulatory processes and templates. Continuous Improvement & Collaboration: Keep up to date with the dynamic regulatory landscape for medical devices. Work closely with internal teams to implement and fulfill safety manuals, regulatory requirements, and internal compliance standards. Act as a role model by promoting Ivoclar’s corporate values of Passion, Vision, and Innovation. What You'll Bring:· Minimum of 5 yrs relevant experience in regulatory affairs or a related field, ideally within the medical device or dental industry.· A bachelor’s degree or MBA in natural, medical, or technical sciences· Proven experience & ability to analyze and interpret complex regulations effectively· Excellent communication skills, both written and verbal, to effectively interact with stakeholders and teams. 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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