About the role

Senior Manager handling International Regulatory Affairs for medical devices at Sonova. Developing global regulatory strategies and managing registrations across multiple regions.

Responsibilities

Develops and executes global regulatory strategies for medical devices, telecom, and battery products across LATAM, MENA, and APAC, 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.
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.

Education: Bachelor’s degree required; preferred in Engineering or Regulatory Affairs.
Experience: Minimum 10 years in GMP, QSR, and ISO-regulated medical device environments, with at least 5 years in regulatory affairs and medical devices.
Leadership: At least 4 years of progressive management experience, including leading cross-functional and geographically dispersed teams.
Specialized Knowledge: Previous Class III medical device experience preferred; strong understanding of global telecom and battery regulations.
Competencies: Highly collaborative, adaptable, self-motivated, with strong interpersonal and communication skills to influence and drive change.
Professional Skills: Strong analytical, decision-making, organizational, and presentation abilities; proven capacity to manage shifting priorities and foster a quality-focused culture.
Technical & Language Skills: Proficiency in MS Office and database management for regulatory tracking; fluent in English, bilingual preferred

Medical, dental and vision coverage*
Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
TeleHealth options
401k plan with company match*
Company paid life/ad&d insurance
Additional supplemental life/ad&d coverage available
Company paid Short/Long-Term Disability coverage (STD/LTD)
STD LTD Buy-ups available
Accident/Hospital Indemnity coverage
Legal/ID Theft Assistance
PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
Paid parental bonding leave
Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
Robust Internal Career Growth opportunities
Tuition reimbursement
Hearing aid discount for employees and family
Internal social recognition platform *Plan rules/offerings dependent upon group Company/location