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.Youllalso 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 theFreedom 2 Savestudent debtprogramandFreeUeducation benefit - an affordable and convenient path to getting a bachelors degree

• A company recognized asa great placeto 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

Werefocused on helping people with diabetes manage their health with life-changing products that provideaccuratedata to drive better-informed decisions.Wererevolutionizing the way peoplemonitortheir glucose levels with our new sensing technology.

The Opportunity

ThisSenior Regulatory Affairs Specialistwill work out of our Alameda CA location in the Diabetes Care Division. As an individual contributorinthe 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 limitedsupervisionyou will execute tasks and partner across business functions.

The individual will be reviewing Labeling Advertising and Promotional materialsdeterminingriskidentifyingdata needed obtaining data and ensuring that the information is reliable and effectively presented to substantiate claims. You may also have opportunities toparticipatein 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 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 programobjectivesand 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 bean important resourcefor the regulatory department to ensure efficient and compliant business processes.This is an exciting opportunity to work inthedynamic and evolving digital health space.

WhatYoullWork 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 managementensuring ontime department deliverables and developing mitigation plans for any issues that areidentified including Ad & Promo process improvements.

• Analyze reports and metrics from tracking toolsidentifyingtrendsand 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 membersdevelopingtheir skills/abilitiesverifyingwork andassistingthem in areas of efficiency and regulatory knowledge.

• Function as a teamleadwhen RA Management is not available toward prioritizing department workstream andfacilitatingissue resolution or escalation.

• Assistwith activities related to NPI and on market products (510K PMA Health Canadasubmissionsand Latin America countries) as needed.

• Determineand communicate promotional content and approval requirements to cross functional teams with limited supervision.

• Assistcompliance with product post-marketing approval requirements as needed.

Required Qualifications

• BachelorsDegree ( 16 years) Related field OR an equivalent combination of education and work experience

• MastersDegree ( 18 years) In Regulatory Affairs preferred and may be used in lieu of direct regulatoryexperience.Minimum3 years 3-4years experiencein a regulated industry (e.g. medical productsnutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance research and development/support scientific affairs operations or relatedarea. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

• Knowledge of:
  Regulatory history guidelines policies standards practicesrequirementsand precedents.
  Regulatory agency structure and processes.
  Principles and requirementsofapplicable regulations and agency guidance.
  Submission/registrationtypes and requirements.
  GxPs (GCPs GLPs GMPs).
  Principles and requirementsofpromotionadvertisingand labeling.
  Ethical guidelinesofthe 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 andmaintainproject plans and timelines.
  Think analytically.
  Organize and track complex information.
  Exercise judgment within broadly defined practices and policies in selecting methodstechniquesand 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 andcross groupdependencies/relationships.

Defineregulatory strategy with supervision.
Follow scientific argumentsidentifyregulatory scientific data needs and with supervisionsolveregulatory 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.

• 3yearof 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 requirementsofpromotionadvertisingand labeling.

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

• Office program skillsto includeWord Excel PowerPoint AdobeAcrobatand SharePoint.

• Bachelors degree in science (biology chemistry microbiology immunology medical technology pharmacy pharmacology) regulatory affairs engineering or medical fields.Masters Degree in Regulatory Affairs and may be used in lieu of direct regulatory experience.