Specialist I, Regulatory Affairs

Sonova Group; Santa Clarita (CA); Hybrid; USD 79,000 - 94,000; Full time

Benefits offered by this job

Medical/Dental/Vision coverage

401k with company match

Hearing aid discount

Tuition reimbursement

PTO & holidays

Job summary

Sonova Group is seeking an International Regulatory Affairs Specialist to drive regulatory strategies and submissions for the MENA region. The role collaborates with in-country teams to secure timely market access for products in Middle East and North Africa.

Required are a science/engineering background and 3+ years of related experience; Master’s is preferred. The role involves travel and a hybrid work model from Valencia, CA, with strong emphasis on risk assessment and post-market obligations.

Qualifications

• Bachelor’s degree in a scientific discipline, engineering, or equivalent experience required.
• Master’s degree in a scientific discipline, engineering, Regulatory Affairs, or equivalent experience preferred.
• At least 3 years of International Regulatory Affairs experience with a Bachelor’s degree, or at least 5 years with a Master’s degree in a directly related specialty.
• Experience with submissions and compliance for Class III medical device companies preferred.
• Strong knowledge of regulatory pathways in Middle East and North Africa markets, ISO 14971, ISO 13485, labeling, clinical requirements, and post-market obligations.
• Strong communication, critical thinking, organizational, project management, collaboration, and attention-to-detail skills.
• Experience with Microsoft Office, Salesforce, SAP, and RIM platforms such as RegDesk or RIMSYS preferred.

Responsibilities

• Plan and execute regulatory activities needed to obtain and maintain approvals within Middle East and North Africa (MENA) markets.
• Support end-to-end submissions, manage timelines, respond to deficiencies, and partner with in-country representatives as needed.
• Provide support to local Regulatory Affairs affiliates who interact with regulatory authorities to help ensure timely approvals and continued product access.
• Participate in sustaining and new product development projects by providing MENA regulatory requirements.
• Review product changes and assess regulatory impact on submission strategy and market registrations.
• Monitor new or amended regulations and support post-market regulatory compliance activities for assigned markets.
• Update regulatory information management tools and support Regulatory Affairs procedures and process improvement activities.

Skills

Regulatory strategy

Regulatory submissions

Project management

Cross-functional collaboration

Regulatory compliance

Communication

Microsoft Office

Salesforce

SAP

RIM platforms

Education

Bachelor's degree in science/engineering

Master's degree in science/engineering/Regulatory Affairs

Tools

RegDesk

RIMSYS

Regulatory information systems

Job description

Valencia, CA (Onsite - Hybrid)

International Regulatory Affairs Specialist – Middle East & North Africa (MENA)

Advanced Bionics is seeking an International Regulatory Affairs Specialist to support regulatory strategies and activities for product approvals and registrations across Middle East and North Africa (MENA) markets. This role is responsible for planning and executing regulatory submissions, maintaining product registrations, supporting regulatory compliance, and partnering with in-country representatives and cross-functional teams to help ensure timely market access and continued product availability.

Responsibilities

• Plan and execute regulatory activities needed to obtain and maintain approvals within Middle East and North Africa (MENA) markets
• Support end-to-end submissions, manage timelines, respond to deficiencies, and partner with in-country representatives as needed
• Provide support to local Regulatory Affairs affiliates who interact with regulatory authorities to help ensure timely approvals and continued product access
• Participate in sustaining and new product development projects by providing MENA regulatory requirements
• Review product changes and assess regulatory impact on submission strategy and market registrations
• Monitor new or amended regulations and support post-market regulatory compliance activities for assigned markets
• Update regulatory information management tools and support Regulatory Affairs procedures and process improvement activities

More about you

• Bachelor’s degree in a scientific discipline, engineering, or equivalent experience required
• Master’s degree in a scientific discipline, engineering, Regulatory Affairs, or equivalent experience preferred
• At least 3 years of International Regulatory Affairs experience with a Bachelor’s degree, or at least 5 years with a Master’s degree in a directly related specialty
• Experience with submissions and compliance for Class III medical device companies preferred
• Strong knowledge of regulatory pathways in Middle East and North Africa markets, ISO 14971, ISO 13485, labeling, clinical requirements, and post-market obligations
• Strong communication, critical thinking, organizational, project management, collaboration, and attention-to-detail skills
• Experience with Microsoft Office, Salesforce, SAP, and RIM platforms such as RegDesk or RIMSYS preferred

Travel

Up to 10%

Internet 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: $79,200 – $94,280 annually . 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.