Specialist Regulatory Affairs

Regulatory Affairs Specialist

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

This 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.

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 Support projects that support the strategic direction of Division, working independently or as part of a team.

Lead and support projects involving AI-driven solutions, ensuring successful implementation and integration into business processes.

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:

• Associates Degree ( 13 years)
• Minimum 1 year experience

Preferred Qualifications:

• Bachelor's degree or an equivalent combination of education and work experience
• Minimum of 2 years' experience in a regulated industry (e.g., medical products, nutritionals, pharma, food). Regulatory area is preferred but may consider quality assurance,, research and development/support, scientific affairs, operations, or related area.
• Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel . Write and edit technical documents.
• Work with cross-functional teams. Work with people from various disciplines and cultures.
• Write and edit technical documents.
• Negotiate internally.
• Pay strong attention to detail.
• Manage projects. Create project plans and timelines.
• Think analytically and critically.
• Organize and track complex information.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Apply business and regulatory ethical standards.
• Prefer some knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society .)
• Office programs skills to include Word, Excel, PowerPoint, Visio and SharePoint.

The base pay for this position is $81,500.00 $141,300.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Regulatory Operations

DIVISION: ADC Diabetes Care

LOCATION: United States > Alameda : 2901 Harbor Bay Parkway

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 5 % of the Time

MEDICAL SURVEILLANCE: No

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)