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Who we are

You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable moments.

We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.

If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.

Join Sonova. Create sense.

Seoul, Korea, Republic of

RA & QA Senior Specialist

Position

RA & QA Senior Specialist

Purpose of the Job

To provide support to the team and gathers information required for monitoring regulatory requirements.

 

 

 

Tasks & Responsibilities
  • Supports more senior colleagues with implementing regulatory programs and policies, and monitoring regulatory activities.
  • Prepares and distributes required documentations for regulatory approvals or monitoring purposes.
    • Managing the domestic approval process for imported products and domestically manufactured products.
  • Compiles and analyses risk databases and ensures that all necessary information has been gathered.
  • Prepares reports using the information for monitoring and reporting purposes.
  • Quality Assurance
    • Quality management of manufactured products, imported products, and components.
    • Performing Internal Audits per GMP, ISO13485
    • Problem-solving skills for quality issues during production (problem identification, solution proposal, procedural support)

 

 

Qualifications

Need to have

Nice to have

Basic Education

University degree in related fields

University or above in engineering, electronics or medical related-profession (biology, pharmacy)

Further Education

 

 

Work Experience

• 7+ years of relevant work experience

• RA/QA/KGMP work experience

• Experienced in quality management

 

 

• Preferred experience in quality management of hearing aids or medical devices.
• Experienced in Class III medical devices.

• Experience in the approval of imported products

Personal Competencies

 

 

Social Competencies

 

 

Leadership Principles

 

 

Professional Competencies

• Knowledge of national regulatory affairs requirements

 

Language(s) / Level

• Intermediate or above proficiency in English

 

IT skills

 

 

Further Requirements

 

 

Sonova is an equal opportunity employer.

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.
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