Sonova AG
Director, Regulatory Affairs - International Markets (Valencia (CA), United Stat
Sonova AG, Valencia, California, us, 91385
Who we are
In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, through our core business brands - Advanced Bionics, Audiological Care, Phonak, Sennheiser (under license) and Unitron - we develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.
Director, Regulatory Affairs - International Markets (Hybird/ Remote)
As the Director of Regulatory Affairs - International Markets for Advanced Bionics, you will lead the regulatory strategy for global markets, ensuring compliance and successful product approvals for Class III medical devices outside North America. This role is critical in driving the regulatory process in international regions, including the EU, APAC, Latin America, and other emerging markets. You will manage a global regulatory team, navigate diverse regulatory landscapes, and ensure that our products meet the highest standards across multiple jurisdictions.
Responsibilities:
Global Regulatory Strategy : Develop and execute regulatory strategies for the approval and commercialization of Class III active implantable medical devices in international markets, ensuring alignment with local requirements, including requirements for telecom and battery certification.International Compliance Oversight : Lead efforts to ensure compliance with global regulatory standards, such as EU MDR, TGA (Australia), PMDA (Japan), ANVISA (Brazil) and other country-specific requirements.Regulatory Submissions : Oversee the preparation and submission of regulatory documents including CE Marking submissions, Technical Files, Health Authority meetings, and post-market surveillance documentation in international markets.Team Leadership:
Manage, mentor, and develop a high-performing team of regulatory professionals located in various regions, ensuring consistency in regulatory approaches and adherence to international standards as well as ensuring compliance with all employment regulations, requirements and performance expectations. This includes the development of direct reports and team members through the use of Performance Objectives, training and development plans, Performance Appraisals, merit processes and Performance Management Plans to ensure success of the team.Cross-Functional Collaboration : Work closely with RA core team members to ensure that global regulatory strategies are integrated into product development, commercialization and design change efforts.Risk Management and Mitigation : Identify potential regulatory risks in international markets, develop mitigation plans, and manage interactions with regulatory bodies to facilitate timely approvals.Market Expansion : When AB plans to enter a new market, ensures compliance with local regulations by assessing regulatory pathways and collaborating with Product Management to define product strategies.Stakeholder Engagement : Serve as the primary point of contact with international regulatory agencies, Notified Bodies, and other relevant authorities, fostering strong relationships to influence regulatory outcomes.Regulatory Intelligence : Monitor and interpret evolving regulatory policies, guidelines, and standards across different regions, advising leadership on potential impacts to business and product strategies.Additional Key Responsibilities:
Supports management with implementation of departmental strategies and company policies.Collaborates with cross functional teams to resolve complex project issues.Effectively plans and organizes team's work to ensure company objectives are met.Creates relationships with cross functional teams to ensure regulatory operational activities are in line with global business prioritiesSupports regulatory agency audits, as required.Contributes to the development or the RA budget by forecasting resource needs, estimating costs for submissions, recertifications and compliance activities and aligning financial planning the strategic regulatory objectives. Once budget is set, manages within plan and escalates if/when issues arise.Other duties as assigned.Travelling Requirement:
Up to 25%
More about you:
Education
Bachelor's Degree in Regulatory Affairs or scientific disciplineNice to Have
Advanced Degree in Regulatory AffairsFurther Education
RA certification (by Regulatory Affairs Professional Society)Nice to Have
Coursework, seminars, and/or other formal trade association training requiredWork Experience
Minimum of 12 years of experience in the area of international regulatory affairs (both submissions and compliance)8+ years of progressive management experience5+ years of experience working with business stakeholders within a cross-functional matrix environment5+ years Class III Medical Device Company in Regulatory AffairsNice to Have
Experience with full product lifecycle with understanding of development lifecycle and various technology methodologies that support that lifecycleDesirable industry background includes battery operated electromechanical systems and/or wireless technologyExperience managing a globally diverse, remote teamPersonal Competencies
Excellent interpersonal, communication (oral and written), teamwork, leadership, organizational and negotiating skillsWrites in a clear, concise, organized and convincing manner for the intended audienceSolid critical analytical and problem solving skills, including consistent and effective problem solvingStrategic Thinking: Capability to develop and implement regulatory strategies that align with organizational goals.Nice to Have• Must be able to work with all levels of management have the ability to influence the actions of others to ensure compliance.• Creates a positive environment within the team and for its customers
Social Competencies
Builds and maintains constructive working relationships characterized by high level of acceptance, confidence, cooperation and mutual respectPromotes cooperation within and outside of the team to achieve goals and deliverablesAbility to work under pressure and meet project timelines across departmentsEffective Communication: Ability to clearly and concisely convey information to diverse audiences, including regulatory bodies, internal and external stakeholdersLeadership Competencies
Strong leadership, diplomatic and motivational skills including the ability to lead up, across and down the businessProven ability to demonstrate drive for results and accountability of business needsStrong mentorship skillsFlexible with proven ability to adjust to and lead a team through shifting priorities, demands and timelinesProfessional Competencies
Demonstrated experience in effectively directing teams and individuals to take action and meet organizational commitments.Manages resources efficiently to achieve timely, successful resultsCoaches team, direct reports, and colleagues for communication, quality and trustworthinessManages and resolves conflicts, disagreements in a constructive mannerAbility to manage competing priorities in a fast paced environmentInfluences, motivates, and challenges othersLanguage(s)/ Level
English/ FluentNice to Have
Fluent in 2nd languageIT Skills
Proficient in Microsoft Office/ including Word, Excel Adobe Acrobat writer and VisioNice to Have• Experience with collaboration tools, JIRA, SharePoint• Experience with SAP
A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova
Don't meet all the criteria? If you're willing to go all in and learn we'd love to hear from you!
What we offer
:
Medical, dental and vision coverage*Health Savings, Health Reimbursement, Flexible Spending/Dependent Care AccountsTeleHealth options401k 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 coverageLegal/ID Theft AssistancePTO (or sick and vacation time), floating Diversity Day, & paid holidays*Paid parental bonding leaveEmployee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)Robust Internal Career Growth opportunitiesTuition reimbursementHearing aid discount for employees and familyInternal social recognition platformD&I focused: D&I council and employee resource groups
*Plan rules/offerings dependent upon group Company/location.
This role's pay range is between: $156,000/yr - $234,000/yr (based on location). This role is also bonus eligible.
How we work:
At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.
Sonova is an equal opportunity employer
We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.
In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, through our core business brands - Advanced Bionics, Audiological Care, Phonak, Sennheiser (under license) and Unitron - we develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.
Director, Regulatory Affairs - International Markets (Hybird/ Remote)
As the Director of Regulatory Affairs - International Markets for Advanced Bionics, you will lead the regulatory strategy for global markets, ensuring compliance and successful product approvals for Class III medical devices outside North America. This role is critical in driving the regulatory process in international regions, including the EU, APAC, Latin America, and other emerging markets. You will manage a global regulatory team, navigate diverse regulatory landscapes, and ensure that our products meet the highest standards across multiple jurisdictions.
Responsibilities:
Global Regulatory Strategy : Develop and execute regulatory strategies for the approval and commercialization of Class III active implantable medical devices in international markets, ensuring alignment with local requirements, including requirements for telecom and battery certification.International Compliance Oversight : Lead efforts to ensure compliance with global regulatory standards, such as EU MDR, TGA (Australia), PMDA (Japan), ANVISA (Brazil) and other country-specific requirements.Regulatory Submissions : Oversee the preparation and submission of regulatory documents including CE Marking submissions, Technical Files, Health Authority meetings, and post-market surveillance documentation in international markets.Team Leadership:
Manage, mentor, and develop a high-performing team of regulatory professionals located in various regions, ensuring consistency in regulatory approaches and adherence to international standards as well as ensuring compliance with all employment regulations, requirements and performance expectations. This includes the development of direct reports and team members through the use of Performance Objectives, training and development plans, Performance Appraisals, merit processes and Performance Management Plans to ensure success of the team.Cross-Functional Collaboration : Work closely with RA core team members to ensure that global regulatory strategies are integrated into product development, commercialization and design change efforts.Risk Management and Mitigation : Identify potential regulatory risks in international markets, develop mitigation plans, and manage interactions with regulatory bodies to facilitate timely approvals.Market Expansion : When AB plans to enter a new market, ensures compliance with local regulations by assessing regulatory pathways and collaborating with Product Management to define product strategies.Stakeholder Engagement : Serve as the primary point of contact with international regulatory agencies, Notified Bodies, and other relevant authorities, fostering strong relationships to influence regulatory outcomes.Regulatory Intelligence : Monitor and interpret evolving regulatory policies, guidelines, and standards across different regions, advising leadership on potential impacts to business and product strategies.Additional Key Responsibilities:
Supports management with implementation of departmental strategies and company policies.Collaborates with cross functional teams to resolve complex project issues.Effectively plans and organizes team's work to ensure company objectives are met.Creates relationships with cross functional teams to ensure regulatory operational activities are in line with global business prioritiesSupports regulatory agency audits, as required.Contributes to the development or the RA budget by forecasting resource needs, estimating costs for submissions, recertifications and compliance activities and aligning financial planning the strategic regulatory objectives. Once budget is set, manages within plan and escalates if/when issues arise.Other duties as assigned.Travelling Requirement:
Up to 25%
More about you:
Education
Bachelor's Degree in Regulatory Affairs or scientific disciplineNice to Have
Advanced Degree in Regulatory AffairsFurther Education
RA certification (by Regulatory Affairs Professional Society)Nice to Have
Coursework, seminars, and/or other formal trade association training requiredWork Experience
Minimum of 12 years of experience in the area of international regulatory affairs (both submissions and compliance)8+ years of progressive management experience5+ years of experience working with business stakeholders within a cross-functional matrix environment5+ years Class III Medical Device Company in Regulatory AffairsNice to Have
Experience with full product lifecycle with understanding of development lifecycle and various technology methodologies that support that lifecycleDesirable industry background includes battery operated electromechanical systems and/or wireless technologyExperience managing a globally diverse, remote teamPersonal Competencies
Excellent interpersonal, communication (oral and written), teamwork, leadership, organizational and negotiating skillsWrites in a clear, concise, organized and convincing manner for the intended audienceSolid critical analytical and problem solving skills, including consistent and effective problem solvingStrategic Thinking: Capability to develop and implement regulatory strategies that align with organizational goals.Nice to Have• Must be able to work with all levels of management have the ability to influence the actions of others to ensure compliance.• Creates a positive environment within the team and for its customers
Social Competencies
Builds and maintains constructive working relationships characterized by high level of acceptance, confidence, cooperation and mutual respectPromotes cooperation within and outside of the team to achieve goals and deliverablesAbility to work under pressure and meet project timelines across departmentsEffective Communication: Ability to clearly and concisely convey information to diverse audiences, including regulatory bodies, internal and external stakeholdersLeadership Competencies
Strong leadership, diplomatic and motivational skills including the ability to lead up, across and down the businessProven ability to demonstrate drive for results and accountability of business needsStrong mentorship skillsFlexible with proven ability to adjust to and lead a team through shifting priorities, demands and timelinesProfessional Competencies
Demonstrated experience in effectively directing teams and individuals to take action and meet organizational commitments.Manages resources efficiently to achieve timely, successful resultsCoaches team, direct reports, and colleagues for communication, quality and trustworthinessManages and resolves conflicts, disagreements in a constructive mannerAbility to manage competing priorities in a fast paced environmentInfluences, motivates, and challenges othersLanguage(s)/ Level
English/ FluentNice to Have
Fluent in 2nd languageIT Skills
Proficient in Microsoft Office/ including Word, Excel Adobe Acrobat writer and VisioNice to Have• Experience with collaboration tools, JIRA, SharePoint• Experience with SAP
A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova
Don't meet all the criteria? If you're willing to go all in and learn we'd love to hear from you!
What we offer
:
Medical, dental and vision coverage*Health Savings, Health Reimbursement, Flexible Spending/Dependent Care AccountsTeleHealth options401k 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 coverageLegal/ID Theft AssistancePTO (or sick and vacation time), floating Diversity Day, & paid holidays*Paid parental bonding leaveEmployee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)Robust Internal Career Growth opportunitiesTuition reimbursementHearing aid discount for employees and familyInternal social recognition platformD&I focused: D&I council and employee resource groups
*Plan rules/offerings dependent upon group Company/location.
This role's pay range is between: $156,000/yr - $234,000/yr (based on location). This role is also bonus eligible.
How we work:
At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.
Sonova is an equal opportunity employer
We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.