At WS Audiology, we are committed to making wonderful sound a part of everyone’s life. To support this mission, we are looking for a Senior Business Quality Specialist to identify and oversee regulatory requirements across the EMEA region.

In this role, you will be a vital part of the Business Quality organization, working closely with peers across EMEA and collaborating with key stakeholders. You will report to the Manager, Business Quality Support EMEA.

What you will do

This is an exciting opportunity to maintain regulatory compliance across EMEA. You will be responsible for identifying local regulatory requirements, including QMS certifications, product registrations, site registrations, and vigilance. The strategic focus of this role is to support EMEA affiliates in quality assurance and local regulatory compliance.

Additionally, you will assist affiliates with audit preparation and execution, process adherence and improvement initiatives, new product introductions (NPI), transfer projects, and post-market processes.

Your new duties will focus on:

Regulatory & Contractual Compliance

• Screen and evaluate applicable regulatory requirements within EMEA countries.
• Keep affiliates informed about regulatory updates, conduct gap analyses, and provide guidance on compliance.
• Train local teams and auditors on EU MDR, ISO 13485, and other regulatory requirements.
• Develop training materials for local regulations.
• Review key contracts (e.g., from key accounts) to ensure regulatory and internal compliance.
• Identify and clarify contractual requirements.
• Collaborate with data analytics experts to establish compliance monitoring systems.

Reporting to Authorities & Vigilance Support

• Support the Global Regulatory Affairs team in vigilance and FSCA activities.
• Serve as the key expert for local teams when reporting to authorities.
• Review and validate communications with regulatory bodies and customers before submission.

Product Registration & Compliance Tracking

• Assist with local product registrations across EMEA as needed.
• Work closely with Global Regulatory Affairs to assess local registration requirements and impact.
• Maintain an up-to-date overview of EMEA registration requirements and ensure internal compliance.

Audits & Quality Support

• Assist in preparing and executing internal and external audits.
• Conduct internal audits at other locations if required.

Project Support

• Contribute to Business Quality projects across EMEA.

What you bring

To succeed in this role, you should have strong expertise in Quality Assurance within the medical device industry, along with a solid Regulatory Affairs background and knowledge of European regulations. The ideal candidate is proactive and collaborative, capable of working with stakeholders across different teams and regions.

Experience:

• Experience in Quality Assurance, preferably in the med-tech industry.
• Proven experience in Regulatory Affairs.
• University degree in Engineering or a related field.
• Strong knowledge of ISO 13485, EU MDR, and other relevant EMEA regulatory requirements.
• Experience in implementing best practices and driving process improvements is highly desirable

Personal competencies:

• Excellent verbal and written communication skills, enabling effective collaboration in global, cross-functional teams.
• A proactive and creative approach to problem-solving with an innovative mindset.
• Strong analytical skills, with the ability to identify gaps and drive improvements.

Our corporate language is English, so you need to be fluent in English, both verbally and in writing.

Who we are

At WS Audiology, 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.

WS Audiology 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.