Regulatory Affairs Senior Specialist

WSA – Wonderful Sound for All; gmina Komorniki; On-site; PLN 120,000 - 180,000; Full time

Job summary

WSA – Wonderful Sound for All is seeking a senior Regulatory Affairs leader to shape and execute regulatory strategies for global R&D in the medical device field. You will drive conformity assessments and oversee product registrations while ensuring compliance across regions.

You will oversee global vigilance activities and collaborate with Operations and cross‑functional teams, including SaMD and AI aspects, to mitigate regulatory risk and enable timely market access.

Qualifications

• 10+ years of Regulatory Affairs experience in the medical device industry.
• Broad Regulatory Affairs experience across active medical devices.
• Extensive experience with global vigilance activities including FDA reporting and recalls.
• Experience with Software as a Medical Device (SaMD), mobile apps, embedded software, and AI in medical devices.
• Master's degree (MSc) in Engineering, Life Sciences or other technical discipline.
• Training in EU MDR 2017/745, ISO 13485 and ISO 14971 Risk Management.

Responsibilities

• Regulatory Affairs activities for global R&D projects, including conformity assessments and MDR expertise.
• Provide Regulatory Affairs support to Operations teams worldwide.
• Represent Regulatory Affairs in WSA change boards.
• Be part of the Global Vigilance Team.
• Support global product registration activities as part of the WSA Global Product Registration Team.

Skills

Regulatory Affairs

Global Vigilance

SaMD / AI in medical devices

Cross-functional collaboration

Stakeholder management

Attention to detail

Regulatory compliance

Education

Master's degree in Engineering or Life Sciences

Job description

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. The role is responsible for shaping and executing integration of regulatory strategies across the organisation and in particular in OPS and R&D, enabling compliant and timely market access. Through strong cross‑functional engagement and influence, the role bridges strategy and execution. By guiding teams at all levels, the role will ensure mitigation of regulatory risks, and hereby enable sustainable business growth for WS Audiology.

What you will do

• Regulatory Affairs activities for global R&D projects, including conformity assessments and serving as a subject matter expert on Medical Device Regulations (MDR).
• Provide Regulatory Affairs support to Operations teams worldwide.
• Represent Regulatory Affairs in WSA change boards.
• Be a part of the Global Vigilance Team.
• Support global product registration activities as a member of the WSA Global Product Registration Team.

What you bring

Experience

• 10+ years of experience within Regulatory Affairs in the medical device industry.
• Broad Regulatory Affairs experience across multiple disciplines related to active medical devices.
• Extensive experience with global vigilance activities, including FDA reporting requirements and product recall obligations.
• Experience working with software in medical devices, including Software as a Medical Device (SaMD), mobile applications, embedded software, and ideally Artificial Intelligence in medical devices.
• Master's degree (MSc) or higher in Engineering, Life Sciences or another relevant technical discipline.
• Documented training in EU MDR 2017/745, ISO 13485 and ISO 14971 Risk Management.

Personal competencies

• Strong understanding of FDA guidance documents and EU MDCG guidelines.
• Self‑driven with a strong delivery‑oriented mindset.
• Able to work independently while effectively solving complex problems in a global organisation.
• Highly organised with a structured approach to planning and execution.
• Excellent collaboration and stakeholder management skills.
• Strong attention to detail and commitment to regulatory compliance.

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.

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.