Senior Product Manager Regulatory Affairs

Valencia CA Remote

Senior Product Manager Regulatory Affairs

The purpose of this role is lead and drive regulatory product management activities for Class III active implantable medical devices ensuring compliance with global regulatory requirements throughout the product lifecycle. Serve as a strategic partner to cross-functional teams by providing regulatory expertise and leadership in labeling packaging and product development initiatives. Champion continuous improvement and regulatory innovation to support global market access and business objectives.

Responsibilities:

• Support the development and maintenance of product labeling (e.g. labels instructions for use direct part marking packaging artwork) to ensure compliance with international regulatory requirements.
• Interpret and apply global and country-specific labeling regulations and standards incorporating changes accurately and on time into product documentation.
• Serve as a regulatory subject matter resource on cross-functional teams providing labeling and packaging input during product development lifecycle updates and global market expansion.
• Collaborate with internal teams (e.g. R&D Quality Marketing Clinical Operations) and external partners to execute labelling solutions that meet compliance and business needs.
• Prepare and maintain regulatory documentation to support global submissions and registrations in coordination with Regulatory Affairs management.
• Participate in identifying process improvements and support implementation to improve labeling workflows documentation quality and regulatory efficiency.
• Contribute to global product release readiness by ensuring applicable labeling and packaging regulatory requirements are met.
• Track and report on relevant regulatory changes sharing potential impacts with internal stakeholders as appropriate.
• Assist with special projects and other responsibilities as assigned by management.
• Other duties as assigned.

Travelling Requirement: up to 20%

More about you:

• Bachelors Degree in scientific discipline / engineering or equivalent
• Advanced Degree in scientific discipline / engineering / Management
• Minimum of 5 years experience in operations logistics product management or project management for Class III active implantable medical devices with a minimum of 2 years experience in labeling for Class III medical devices. of progressive experience in Quality or Engineering in a regulated Industry
• 5 years experience in global regulatory affairs or labeling for Class III active implantable medical devices preferred
• Proven ability to engage and communicate effectively with all levels of the organization including executive leadership

• Deep knowledge of global labeling requirements and regulatory standards for Class III active implantable medical devices
• Strong analytical and problem-solving skills with the ability to anticipate regulatory challenges and develop proactive solutions
• In-depth understanding of international regulatory frameworks including FDA EU MDR Health Canada and other global authorities

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

Dont meet all the criteria If youre willing to go allin and learn wed 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 roles pay range is between: $82400/yr - $123600/yr compensation is based on skillset and location. This role is also 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.