Driven by the passion to improve quality of people’s lives, WSA continues to grow as a market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively.

As our new Senior Regulatory Affairs Specialist, you will act as a key regulatory partner to R&D, ensuring that innovative hearing solutions – including software and AI-driven products – meet global regulatory requirements. This is an individual contributor role with significant impact, where you will drive regulatory excellence, support complex R&D projects, and help translate regulatory complexity into clear, actionable solutions.

What you will do

• Lead regulatory support for R&D projects, ensuring correct classification, intended use, regulatory strategy, and final product release

• Drive regulatory strategy for hearing aids, software, apps, and AI-based medical device projects, including implementation of AI-related requirements

• Advise on global medical device regulations including EU MDR, US FDA 21 CFR, and ISO 13485 requirements

• Ensure compliant technical documentation, labeling, Declaration of Conformity, and product standards

• You will play a key role in supporting Regulatory Affairs activities across our Key Account projects, driving high-quality and compliant regulatory outcomes.

• Provide ad‑hoc guidance to Marketing and R&D on a variety of clinical regulatory questions.

• Optimize regulatory processes and contribute to continuous improvement initiatives

• Collaborate with internal stakeholders (R&D, Business Quality) and interact with regulatory authorities when required.
  

What you bring

Experience

• Master’s degree in Engineering, Technical Sciences, or similar

• Around 10 years of experience within Regulatory Affairs in a large, global MedTech organization

• Strong expertise in EU MDR (2017/745), US FDA 21 CFR 820, ISO 13485, and ISO 14971

• Solid experience supporting R&D projects, particularly in electro‑medical, software‑driven, app‑based, and AI‑enabled medical devices

• Proven experience with technical documentation, product classification, intended use, and regulatory strategy

• Fluency in English (written and spoken).

Personal competencies

• Analytical and structured with the ability to navigate regulatory complexity

• Solution-oriented and confident in solving problems in dynamic or ambiguous environments

• Collaborative and supportive team player who contributes to a strong RA community

• Clear and persuasive communicator across technical and non-technical stakeholders

• Self-driven individual contributor who takes ownership and drives progress

• Comfortable working in an international and cross-functional environment.
  

Who we are

At WSA, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful? We can't wait to hear from you.

WSA is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.