Director, Regulatory Affairs - International Markets

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 priorities
• Supports 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 discipline

Nice to Have

• Advanced Degree in Regulatory Affairs

Further Education

• RA certification (by Regulatory Affairs Professional Society)

Nice to Have

• Coursework, seminars, and/or other formal trade association training required

Work Experience

• Minimum of 12 years of experience in the area of international regulatory affairs (both submissions and compliance)
• 8+ years of progressive management experience
• 5+ years of experience working with business stakeholders within a cross-functional matrix environment
• 5+ years Class III Medical Device Company in Regulatory Affairs

Nice to Have

• Experience with full product lifecycle with understanding of development lifecycle and various technology methodologies that support that lifecycle
• Desirable industry background includes battery operated electromechanical systems and/or wireless technology
• Experience managing a globally diverse, remote team

Personal Competencies

• Excellent interpersonal, communication (oral and written), teamwork, leadership, organizational and negotiating skills
• Writes in a clear, concise, organized and convincing manner for the intended audience
• Solid critical analytical and problem solving skills, including consistent and effective problem solving
• Strategic 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 respect
• Promotes cooperation within and outside of the team to achieve goals and deliverables
• Ability to work under pressure and meet project timelines across departments
• Effective Communication: Ability to clearly and concisely convey information to diverse audiences, including regulatory bodies, internal and external stakeholders

Leadership Competencies

• Strong leadership, diplomatic and motivational skills including the ability to lead up, across and down the business
• Proven ability to demonstrate drive for results and accountability of business needs
• Strong mentorship skills
• Flexible with proven ability to adjust to and lead a team through shifting priorities, demands and timelines

Professional Competencies

• Demonstrated experience in effectively directing teams and individuals to take action and meet organizational commitments.
• Manages resources efficiently to achieve timely, successful results
• Coaches team, direct reports, and colleagues for communication, quality and trustworthiness
• Manages and resolves conflicts, disagreements in a constructive manner
• Ability to manage competing priorities in a fast paced environment
• Influences, motivates, and challenges others

Language(s)/ Level

• English/ Fluent

Nice to Have

• Fluent in 2nd language

IT Skills

• Proficient in Microsoft Office/ including Word, Excel Adobe Acrobat writer and Visio

Nice 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 allin 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 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
• D&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.