Associate Director, Regulatory Affairs – Us New Product Introductions & On-Market Changes (On-Site)

5=7 years

$146,700.00 – $293,300.00

Alameda

10 March 10, 2025

Job Description

Job Type: Full Time Education: B.Com/ BBA/ MBA/ M.Com/ B.Sc/ M.Sc/ B.Tech/ M.Tech/ BE/ ME Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Director, Regulatory Affairs – US New Product Introductions & On-Market Changes (On-Site)
Location: United States - California - Alameda
Category: Regulatory Affairs

About Abbott:
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 114,000 colleagues serve people in more than 160 countries.

Working at Abbott:
At Abbott, you can do work that matters, grow and learn, care for yourself and your 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 obtaining a bachelor’s degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company 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.

The Opportunity:
This Associate Director, Regulatory Affairs – US New Product Introduction and On-Market Changes will work on-site at our Alameda, CA location in the Diabetes Care Division. We are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Our FreeStyle Libre continuous glucose monitors have revolutionized how roughly 6 million people worldwide manage their diabetes.

This is an exciting opportunity with responsibilities for US submissions for new product introductions, including breakthrough advancements in diabetes management and digital health technology solutions. Projects include our continuous glucose-ketone monitoring system that will monitor both glucose and ketone levels in one sensor. The role also includes responsibilities for regulatory support for on-market change management and manufacturing sites. The individual has department-level influence with experience in US submissions (PMA / 510k / DeNovo), people management and development, and is generally recognized as an expert resource both within Abbott and externally.

Responsibilities:

Develop global regulatory strategies for product development and planning throughout the product lifecycle.
Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
Provide technical leadership and strategic input on complex issues to business units.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other regulatory and related teams.
Develop and communicate a vision for the assigned organizational unit.
Create project plans and timelines.
Lead functional groups in the development of relevant data to complete a regulatory submission.
Write and edit technical documents.
Recruit, develop, and manage regulatory professionals.
Evaluate performance of and assist in career development planning for subordinates.
Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
Negotiate with regulatory authorities during the development and review process to ensure submission approval.
Review and approve labeling to ensure compliance.
Monitor emerging issues and identify solutions.
Negotiate internally and externally with regulatory agencies.
Identify the need for new regulatory policies, processes, and SOPs and approve them.
Evaluate regulatory risks of corporate policies.
Oversee processes involved with maintaining annual licenses, registrations, listings, and patent information.
Ensure compliance with product post-marketing approval requirements.
Develop, implement, and manage appropriate SOPs and systems to track and manage product-associated events.
Actively contribute to the development and functioning of the crisis/issue management program.
Analyze product-associated problems and develop proposals for solutions.
Oversee systems to ensure that product safety issues and product-associated events are reported to regulatory agencies.
Provide regulatory input for product recalls and recall communications.

Education and Experience:

Required:

Bachelor's degree.
5-7 years of experience in a regulated industry (e.g., medical products).
5-7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or a related area.
Higher education may compensate for years of experience.

Preferred:

Bachelor's degree in computer science, math, engineering, or medical fields.
M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
Previous experience with 510k / PMA / DeNovo submissions or class I / II exempt software devices.
7-10 years of experience in a regulated industry. Regulatory area is preferred but may consider software or systems research and development, or related area.
Ability to work effectively on cross-functional teams.
Must be able to juggle multiple and competing priorities.
Strong written, verbal, presentation, and organizational skills.
Experience with FDA QSR.
Has a sound knowledge of a variety of alternatives and their impact on the business.

Apply Now:
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews and @AbbottGlobal.

Compensation:
The base pay for this position is $146,700.00 – $293,300.00. In specific locations, the pay range may vary from the range posted.

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Associate Director, Regulatory Affairs – Us New Product Introductions & On-Market Changes (On-Site)

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