New · posted Nov 13
Abbott · Medical Devices
Associate Director, Regulatory Affairs - Diabetes Care
- Alameda, CA
- On-site
- Full-time
- Director
The role
This Associate Director, Regulatory Affairs will work on-site at our Alameda, CA location in the Diabetes Care Division. 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. Our FreeStyle Libre continuous glucose monitors have revolutionized the way roughly 7 million people worldwide manage their diabetes.
This is an exciting opportunity to shape and execute regulatory strategies across the total product life cycle, driving innovation in next-generation diabetes management and digital health technology solutions. The individual has department level influence with experience in leading and developing high-performing teams and is generally recognized as an expert resource both within Abbott and externally. The individual will play a critical role in anticipating and influencing evolving regulations and guidance, lead complex management change initiatives, interface with outside regulatory agencies and trade associations, and advise executive management with strategic insights and key regulatory metrics.
This is an opportunity to make a meaningful impact on patient access and innovation, while elevating your visibility and leadership within a dynamic, mission-driven organization.
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 122,000 colleagues serve people in more than 160 countries.
What you need
Required Qualifications
- Bachelor's degree
- 5-7 years’ experience in a regulated industry (e.g., medical products).
- 5-7 years’ experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
Preferred Qualificationsnice to have
- 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.)
- Experience with Class III US and EU submissions and Software as a Medical Device (SaMD)
- Experience with FDA QSR and EU MDR and interfacing directly with regulatory authorities.
- 7-10 years’ 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.
- Has a sound knowledge of a variety of alternatives and their impact on the business.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
What you'll do
What You’ll Work On
- 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 and to business units.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
- Develop and communicate a vision for the organizational unit assigned.
- 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 assists 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 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 system to ensure that product safety issues and product-associated events are reported to regulatory agencies.
- Provide regulatory input for product recalls and recall communications.
Pay and benefits
$148,700 – $297,300 a year
Employer providedThe base pay for this position is
$148,700.00 – $297,300.00
In specific locations, the pay range may vary from the range posted.
Free medical coverage in Health Investment Plan (HIP) PPO
Retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit
Career development
Where you'll work
Alameda, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Alameda, CAWorking conditions
Standard
TRAVEL
Yes, 15 % of the Time
MEDICAL SURVEILLANCE
No
JOB FAMILY
Regulatory Operations
DIVISION
ADC Diabetes Care
LOCATION
United States > Alameda : 2901 Harbor Bay Parkway
From the posting
About Abbott
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.
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
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.
Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Job intelligence
The context around this role
Live data · November 13, 2026
Salary intelligence
How the pay compares
This role's midpoint is 4% below the US median for Regulatory Strategy roles at this level.
This roleEmployer provided
Director roles in California7 roles publishing pay
Director roles in the US46 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $148,700 | — | $297,300 |
| California (middle half) | $235,750 | $264,000 | $328,250 |
| All US (middle half) | $217,125 | $232,500 | $268,875 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 96 open Regulatory Strategy roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 43 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Regulatory submissions5
- GMP and compliance4
- Documentation and SOPs3
- Data and digital systems3
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Strategy work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilanceNamed in the posting
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissions
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- IMDRFIMDRF(official source, opens in a new tab)International Medical Device Regulators Forum guidance, including software as a medical device
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devices
- EUEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- FDAFDA eSTAR(official source, opens in a new tab)The electronic submission template for 510(k) and De Novo requests
- ISOISO 14155(official source, opens in a new tab)Good clinical practice for clinical investigations of medical devices
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
Company hiring pulse
Abbott on Regulatory Jobs
- 119
- Open roles
- 119
- Distinct roles
- 33
- Locations
By discipline
- Quality62 52%
- Regulatory31 26%
- Clinical26 22%
By level
- Senior & Principal56 47%
- Associate & Specialist35 29%
- Manager25 21%
More roles at Abbott
- View role
Principal Regulatory Affairs Specialist – Vascular
Santa Clara, CASenior & PrincipalMedical Devices$100K–$200K
- View role
Clinical Affairs Specimen Operations Specialist
Madison, WIAssociate & SpecialistMedical Devices$61K–$123K
- View role
Quality Control Chemist
Minnetonka, MNAssociate & SpecialistMedical Devices$61K–$123K
- View role
Manager, Laboratory Supplier Quality
Madison, WIManagerMedical Devices$99K–$199K
Similar Regulatory Strategy roles elsewhere
- View role
Associate Director, Device Regulatory Affairs
BiogenRemote, USDirectorMedical Devices$160K–$220K
- View role
Senior Director, Regulatory Affairs Strategy & BD&L
AlconFort Worth, TXDirectorMedical Devices$218K–$283K
Associate Director, Regulatory Affairs - Diabetes Care at Abbott
Open until filled. $149K–$297K a year, employer provided.