Regulatory specialist Jobs in Oakland, CA

The Opportunity

This Senior Regulatory Affairs Specialist will work out of our Alameda, CA location in the Diabetes Care Division. As an individual contributor in the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department to ensure efficient and compliant business processes and environment are followed. With limited supervision you will execute tasks and partner across business functions.

The individual will be reviewing Labeling, Advertising and Promotional materials, determining risk, identifying data needed, obtaining data, and ensuring that the information is reliable and effectively presented to substantiate claims. You may also have opportunities to participate in worldwide regulatory submissions.

This is a broad scoped position with strong opportunity for growth and career development based on performance.

As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including generative AI technologies designed to help millions of patients in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Prior experience working with software development teams, diabetes management devices (e.g. insulin dosing algorithms), and artificial intelligence / machine learning technologies is preferred. This role will also be an important resource for the regulatory department to ensure efficient and compliant business processes. This is an exciting opportunity to work in the dynamic and evolving digital health space.

What You’ll Work On

• Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input.
• Coordinate RA Ad & Promo activities among internal Regulatory functions and Division cross functional teams. Facilitate development and process discussions toward implementing advertising and promotion improvement processes.
• Support RA Ad & Promo management ensuring on time department deliverables and developing mitigation plans for any issues that are identified, including Ad & Promo process improvements.
• Analyze reports and metrics from tracking tools, identifying trends and ramifications.
• Lead and execute projects that support the strategic direction of Division, working independently or as part of a team.
• Lead junior RA Ad & Promo team members, developing their skills / abilities, verifying work, and assisting them in areas of efficiency and regulatory knowledge.
• Function as a team lead when RA Management is not available toward prioritizing department workstream and facilitating issue resolution or escalation.
• Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed.
• Determine and communicate promotional content and approval requirements to cross functional teams with limited supervision.
• Assist compliance with product post-marketing approval requirements as needed.

Required Qualifications

Preferred Qualifications

The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.