Valencia, CA - Hybrid (3 days onsite)
Senior Specialist, Regulatory AffairsAdvanced 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. The Senior Specialist will collaborate with cross-functional teams throughout the product development lifecycle to ensure regulatory compliance, maintain product registrations, and support timely market approvals.
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%
A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at SonovaDon't meet all the criteria? If you're willing to go all in and learn we'd love to hear from you!
We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact Sonova Human Resources
What we offer:- Medical, dental and vision coverage*
- Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
- TeleHealth options
- 401k plan with company match*
- Company paid life/ad&d insurance
- Additional supplemental life/ad&d coverage available
- Company paid Short/Long-Term Disability coverage (STD/LTD)
- STD LTD Buy-ups available
- Accident/Hospital Indemnity coverage
- Legal/ID Theft Assistance
- PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
- Paid parental bonding leave
- Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
- Robust Internal Career Growth opportunities
- Tuition reimbursement
- Hearing aid discount for employees and family
- Internal social recognition platform
*Plan rules/offerings dependent upon group Company/location.
This role's pay range is between: $100,320 - $125,400 annually. Actual compensation will vary based on geographic location, qualifications, and experience. This role is also commission eligible/bonus eligible.
