Regional Regulatory Lead overseeing EUCAN regulatory strategy for pharmaceutical projects and products. Planning submissions, coordinating meetings, and collaborating with regulatory authorities.
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.
Requirements
- 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
Benefits
- 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
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