Senior Specialist Regulatory Affairs

Job Description

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

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 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

• Bachelors Degree (± 16 years), Related field OR an equivalent combination of education and work experience

• Masters Degree (± 18 years), In Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.Minimum 3 years, 3-4 years experience in a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

• Knowledge of:
  Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
  Regulatory agency structure and processes.
  Principles and requirements of applicable regulations and agency guidance.
  Submission/registration types and requirements.
  GxPs (GCPs, GLPs, GMPs).
  Principles and requirements of promotion, advertising and labeling.
  Ethical guidelines of the regulatory profession.

• Communication Skills or Ability to:
  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.
  Negotiate internally and externally with regulatory agencies.

• Cognitive Skills or Ability to:
  Pay strong attention to detail.
  Manage projects.
  Create and maintain project plans and timelines.
  Think analytically.
  Organize and track complex information.
  Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  Has broad knowledge of various technical alternatives and their potential impact on the business.
  Exercise good and ethical judgment within policy and regulations.
  Use in-depth knowledge of business functions and cross group dependencies/ relationships.

Define regulatory strategy with supervision.
Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.

Preferred Qualifications

• 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.

• 3+ year of Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of labeling, promotional, and or advertising materials is highly desired

• Principles and requirements of promotion, advertising and labeling.

• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

• Office program skills to include Word, Excel, PowerPoint, Adobe Acrobat and SharePoint.

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields. Master’s Degree in Regulatory Affairs and may be used in lieu of direct regulatory experience.