Senior Specialist, Regulatory Affairs
Sonova AG
Summary
Advanced Bionics is seeking a Senior Specialist, Regulatory Affairs to develop and execute regulatory strategies supporting product approvals and registrations across international markets, with a focus on the Asia-Pacific (APAC) region. This hybrid role requires strong experience with Class III medical devices, PMA submissions, and global regulatory requirements.
Job description
Responsibilities
- Develop and execute regulatory strategies to obtain and maintain product approvals and registrations across international markets, including APAC, EU, Canada, LATAM, and MENA.
- Prepare and manage regulatory submissions, including PMAs, PMA supplements, 510(k)s, IDE applications, CE marking applications, and international product registrations.
- Provide regulatory guidance throughout the new product development lifecycle, including design controls, manufacturing processes, and sustaining engineering activities.
- Lead end-to-end regulatory submissions, manage timelines, respond to regulatory deficiencies, and collaborate with regulatory authorities and in-country partners.
- Support post-market regulatory compliance, including complaint reporting, vigilance activities, change assessments, and maintenance of existing product approvals.
- Monitor evolving international regulatory requirements and provide guidance on product labeling, testing, clinical requirements, and market-specific compliance.
- Collaborate with Regulatory Affairs, Clinical Affairs, Quality, and Development teams to support product releases, regulatory audits, and continuous process improvements.
More about you
- Bachelor's degree in a scientific discipline, engineering, or equivalent experience required.
- Minimum of 8 years of global regulatory affairs experience within Class III medical device companies with a bachelor's degree, or 5 years with a master's degree in a directly related specialty.
- Hands-on experience with Class III medical device regulatory submissions, including PMA submissions, and regulatory activities throughout the product development lifecycle.
- Strong knowledge of international medical device regulations, including APAC regulatory requirements, EU MDR, and North American regulatory pathways.
- Understanding of medical device design controls, risk management (ISO 14971), quality management systems (ISO 13485), labeling, clinical, and post-market regulatory requirements.
- Strong communication, project management, organizational, and problem-solving skills with the ability to collaborate across global cross-functional teams.
- Proficiency with Microsoft Office and familiarity with regulatory information management platforms such as RegDesk and RIMSYS.
- Master's degree in a scientific discipline, engineering, or Regulatory Affairs, or Regulatory Affairs Certification (RAC), preferred.
- Travel: Up to 10%
Requirements
- Bachelor's degree in a scientific discipline, engineering, or equivalent experience
- Minimum of 8 years of global regulatory affairs experience within Class III medical device companies with a bachelor's degree, or 5 years with a master's degree in a directly related specialty
- Hands-on experience with Class III medical device regulatory submissions, including PMA submissions
- Strong knowledge of international medical device regulations, including APAC regulatory requirements, EU MDR, and North American regulatory pathways
- Understanding of medical device design controls, risk management (ISO 14971), quality management systems (ISO 13485), labeling, clinical, and post-market regulatory requirements
- Strong communication, project management, organizational, and problem-solving skills
- Proficiency with Microsoft Office and familiarity with regulatory information management platforms such as RegDesk and RIMSYS
- Master's degree in a scientific discipline, engineering, or Regulatory Affairs, or Regulatory Affairs Certification (RAC), preferred
- Travel: Up to 10%
Benefits
- Medical, Dental & Vision
- Health Savings Account
- Health Reimbursement Account
- Flexible Spending Account
- Telehealth Options
- 401(k) Matching
- Life Insurance
- AD&D Insurance
- Short-Term Disability
- Long-Term Disability
- Accident Indemnity
- Hospital Indemnity
- Legal Assistance
- ID Theft Assistance
- Paid Time Off
- Paid Holidays
- Paid Parental Leave
- Employee Assistance Program
- Tuition Reimbursement
- Hearing Aid Discount
Company overview
Sonova Holding AG is a globally recognized Swiss medical device company specializing in innovative hearing care solutions. Founded in 1947 and headquartered in Stäfa, Switzerland, Sonova has established itself as one of the world's largest providers in the hearing care sector, holding approximately 24% of the global hearing aid market. The company operates through four core business divisions: Hearing Instruments, Audiological Care, Consumer Hearing, and Cochlear Implants. Sonova's diverse portfolio includes renowned brands such as Phonak, Unitron, Advanced Bionics, AudioNova, and licensed Sennheiser products. With over 17,990 employees worldwide, the company generates annual revenues exceeding CHF 3.6 billion and serves customers in more than 100 countries. Sonova's comprehensive offerings range from digital hearing aids and cochlear implants to wireless communication systems and professional audiological care services. As a component of the Swiss Market Index, Sonova maintains research facilities in Switzerland, Canada, and the United States, with manufacturing plants strategically located across Switzerland, China, and Vietnam. The company's mission centers on enabling people to experience the joy of hearing and live life without limitations through cutting-edge audio technology and comprehensive hearing care solutions.