Specialist II, Regulatory Affairs

Sonova AG • Santa Clarita, CA

123d • Hybrid

About The Position

Prepare submissions to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. Participate in activities to ensure compliance with worldwide regulatory requirements.

Requirements

• Bachelor’s degree in a scientific discipline, engineering, or equivalent required
• Minimum of 2–3 years of regulatory affairs experience, with Class II or Class III medical devices required
• Strong knowledge of regulatory requirements, standards, and submission processes, including FDA and EU regulations
• Demonstrated ability to work independently and collaboratively in a fast-paced, matrixed environment, managing multiple priorities and stakeholders effectively.
• Excellent written and verbal communication skills, including technical writing and preparation of regulatory submissions; ability to communicate across organizational levels.
• Proven problem-solving, analytical, and critical-thinking skills, with the ability to assess regulatory risk and respond efficiently to business needs.
• Proficient in English required
• A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

Nice To Haves

• advanced degree (Engineering, Management, or related field) preferred
• experience with global regulatory frameworks (FDA, EU MDR, etc.) preferred
• experience supporting implantable medical devices preferred
• proficiency in an additional language preferred

Responsibilities

• Support project teams as a regulatory specialist by providing input on regulatory requirements and reviewing documentation for compliance under guidance from senior staff.
• Assist in preparing regulatory submissions (e.g. PMA supplements, EC marking applications, product registrations) to obtain approvals for commercial distribution.
• Review product and manufacturing changes for compliance with applicable regulations and standards, escalating issues as needed.
• Review and assess supplier change notifications for potential regulatory impact; coordinate with internal stakeholders to determine required actions and ensure compliance.
• Coordinate and support responses to regulatory agency inquires; may participate in meetings as an observer but does not serve as primary contact.
• Contribute to the development and improvement of departmental policies and procedures through feedback and implementation support.
• Support business efforts to comply with new and existing regulations and international standards.
• Foster relationships across business units and functional groups to share best practices.
• Support regulatory audits as required.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level