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.

This role requires:

• 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.

Please refer to job description.