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Sonova Group · 4 hours ago

Senior Manager, International Regulatory Affairs

Santa Clarita, CA

Full-time

Hybrid

Senior Level, Lead/Staff

$126K/yr - $190K/yr

10+ years exp

Sonova Group is a company focused on regulatory affairs for medical devices and telecommunications. The Senior Manager, International Regulatory Affairs will develop and implement regulatory programs while managing international pre-market and post-market registrations for various products, ensuring compliance with international standards.

Medical Device

Responsibilities

Develops and executes global regulatory strategies for medical devices, telecom, and battery products across LATAM, MENA, and APAC (excluding China), ensuring compliance with international standards

Manages pre- and post-market registrations and submissions, including homologation for Class III medical devices, battery certification, and telecom approvals, delivered on time to support product launches

Manage Battery and Telecom Certifications (worldwide)

Leads and coaches teams, driving performance management, employee engagement, goal setting, and adherence to company policies while fostering a dynamic, improvement-focused work environment

Provides regulatory intelligence and guidance to cross-functional teams, aligning strategies with commercial objectives and ensuring compliance in labeling, technical requirements, and external standards

Builds and maintains strong relationships with regulatory authorities, local stakeholders, and internal departments, serving as the primary contact for regulatory projects

Oversees complex regulatory documentation and processes, ensuring timely submissions, effective communication with leadership, and readiness for regulatory audits

Supports organizational strategy and operations by contributing to budget planning, leading cross-divisional projects, and implementing processes that align regulatory activities with global business priorities

Qualification

Regulatory AffairsMedical DevicesTelecom RegulationsBattery CertificationsGMP ExperienceQSR KnowledgeISO StandardsAnalytical SkillsMS Office ProficiencyDatabase ManagementBilingual PreferredFluent in EnglishLeadershipCommunication Skills

Required

Bachelor's degree required; preferred in Engineering or Regulatory Affairs

Minimum 10 years in GMP, QSR, and ISO-regulated medical device environments, with at least 5 years in regulatory affairs and medical devices

At least 4 years of progressive management experience, including leading cross-functional and geographically dispersed teams

Highly collaborative, adaptable, self-motivated, with strong interpersonal and communication skills to influence and drive change

Strong analytical, decision-making, organizational, and presentation abilities; proven capacity to manage shifting priorities and foster a quality-focused culture

Proficiency in MS Office and database management for regulatory tracking; fluent in English