Senior Regulatory Affairs Specialist

WS Audiology Group; Poznań; On-site; PLN 180,000 - 280,000; Full time

Job summary

WS Audiology Group in Poznań, Poland invites a Senior Regulatory Affairs Specialist to drive global regulatory strategies for medical devices and enable timely market access. You will work with R&D, Operations and cross-functional teams worldwide.

The role requires 5+ years in Regulatory Affairs for medical devices, MSc in engineering or life sciences, and training in EU MDR 2017/745, ISO 13485 and ISO 14971. You will ensure compliance and lifecycle management globally.

Qualifications

• 5+ years of Regulatory Affairs experience in the medical device industry.
• Broad RA experience across disciplines related to active medical devices.
• Extensive experience supporting global product registrations, regulatory compliance activities, change management processes, and lifecycle maintenance.
• Master's degree (MSc) in Engineering, Life Sciences or another relevant technical discipline.
• Documented training in EU MDR 2017/745, ISO 13485 and ISO 14971 Risk Management.

Responsibilities

• Support global regulatory strategies for medical devices and enabling timely market access.
• Provide Regulatory Affairs support to Operations teams worldwide.
• Coordinate Regulatory Affairs Change Board activities and cross-functional collaboration.
• Assist with global product registrations as part of the Global Product Registration Team.
• Collaborate with cross-functional stakeholders to ensure regulatory compliance and lifecycle management across markets.

Skills

Regulatory Affairs

Product registration

MDR 2017/745

ISO 13485

ISO 14971

Education

MSc degree

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.

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 a Senior Regulatory Affairs Specialist, you will support the execution of global regulatory strategies that enable compliant and timely market access for WSA's medical devices. Working closely with R&D, Operations and cross-functional stakeholders, you will contribute your regulatory expertise to ensure compliance, mitigate regulatory risks and support successful product development and commercialization worldwide.

What you will do

• Support 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.
• Coordinate Regulatory Affairs Change Board activities, ensuring effective internal collaboration within the Global Regulatory Affairs function and representing RA in cross-functional initiatives.
• Support global product registration activities as a member of the WSA Global Product Registration Team.
• Collaborate with cross-functional stakeholders to ensure regulatory compliance and successful product lifecycle management across international markets.

What you bring

Experience

• 5+ 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 supporting global product registrations, regulatory compliance activities, change management processes, and product lifecycle maintenance.
• Master's degree (MSc) 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 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.

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.