The business problem Sonova is trying to solve is to lead and drive regulatory product management activities for Class III active implantable medical devices, ensuring compliance with global regulatory requirements throughout the product lifecycle.
Requirements
- Proficient with Microsoft Office suite.
- Experienced with Oracle, SAP and Salesforce
- Experienced with cloud-based systems.
- Deep knowledge of global labeling requirements and regulatory standards for Class III active implantable medical devices.
- In-depth understanding of international regulatory frameworks, including FDA, EU MDR, Health Canada, and other global authorities.
- Strong analytical and problem-solving skills, with the ability to anticipate regulatory challenges and develop proactive solutions.
- Expert-level writing, proofreading, and data management skills, with a focus on clarity, accuracy, and compliance.
Responsibilities
- Support the development and maintenance of product labeling (e.g., labels, instructions for use, direct part marking, packaging artwork) to ensure compliance with international regulatory requirements.
- Interpret and apply global and country-specific labeling regulations and standards, incorporating changes accurately and on time into product documentation.
- Serve as a regulatory subject matter resource on cross-functional teams, providing labeling and packaging input during product development, lifecycle updates, and global market expansion.
- Collaborate with internal teams (e.g., R&D, Quality, Marketing, Clinical, Operations) and external partners to execute labelling solutions that meet compliance and business needs.
- Prepare and maintain regulatory documentation to support global submissions and registrations in coordination with Regulatory Affairs management.
- Participate in identifying process improvements and support implementation to improve labeling workflows, documentation quality, and regulatory efficiency.
- Contribute to global product release readiness by ensuring applicable labeling and packaging regulatory requirements are met.
Other
- Bachelor’s Degree in scientific discipline / engineering or equivalent.
- Minimum of 5 years’ experience in operations, logistics, product management or project management for Class III active implantable medical devices with a minimum of 2 years’ experience in labeling for Class III medical devices.
- Up to 20% travel requirement
- Proven ability to engage and communicate effectively with all levels of the organization, including executive leadership.
- Maintains professionalism and composure in high-stakes regulatory discussions and decision-making forums.
