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 

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.