Senior Specialist, Regulatory Affairs

Sonova Group; Santa Clarita (CA); Hybride; USD 100 000 - 125 000; Plein temps

Avantages offerts par ce poste

Medical, dental and vision coverage

401k plan with company match

Tuition reimbursement

Paid parental bonding leave

Employee Assistance Program

Résumé du poste

Sonova is seeking a Senior Specialist, Regulatory Affairs in Valencia, CA. This hybrid role supports product approvals and registrations across international markets, with emphasis on APAC regulatory requirements for Class III devices.

The position emphasizes regulatory submissions, lifecycle management, and collaboration with Quality, Clinical, and Development teams to ensure compliance and timely market access.

Qualifications

• Bachelor’s degree in a scientific discipline or engineering.
• Regulatory experience in Class III medical devices with PMA experience is required.
• Familiarity with international medical device regulations (APAC, EU MDR, NA pathways).

Responsabilités

• Develop and execute regulatory strategies to obtain and maintain approvals across APAC, EU, Canada, LATAM, and MENA.
• Prepare PMAs, PMA supplements, 510(k)s, IDEs, CE marking and international registrations.

Connaissances

Regulatory affairs

PMA submissions

Class III medical devices

Cross-functional collaboration

Regulatory strategy

Regulatory guidance

Design controls & ISO 14971

Quality systems (ISO 13485)

Regulatory labeling & post-market

Formation

Bachelor's degree in a scientific discipline

Master's degree or RAC preferred

Outils

RegDesk

RIMSYS

Description du poste

Senior Specialist, Regulatory Affairs

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. 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.

Valencia, CA – Hybrid (3 days onsite)

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%

Connectivity:

A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

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.

How we work:

At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.

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.