Associate Director, Regulatory Affairs (on-site)

Thornton Tomasetti; Alameda (CA); On-site; USD 149,000 - 297,000; Full time

Benefits offered by this job

Career development

Health coverage

Retirement plan

Tuition reimbursement

Job summary

Abbott in Alameda, CA is seeking an Associate Director Regulatory Affairs to shape global regulatory strategies across the product life cycle in Diabetes Care. We focus on innovative glucose monitoring technologies and drive strategic regulatory initiatives.

You will lead and develop high-performing teams, interface with agencies, and drive regulatory submissions for US and EU, ensuring compliance and timely approvals.

Qualifications

• Bachelor's degree in a regulated field or related area.
• 5-7 years’ experience in a regulated industry (e.g., medical products).
• 5-7 years’ experience in regulatory preferred but may consider QA, R&D/support, scientific affairs, operations, or related area.

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 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.

Skills

Regulatory affairs expertise

Cross-functional collaboration

Regulatory submissions

Communication skills

Education

Bachelor's degree

M.S. in technical area or MBA is preferred

Ph.D. in a technical area or law is helpful

RAC certification

Job description

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 115,000 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 family, be your true self and live a full life. You’ll also have access to:

Benefits

• 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.

The Opportunity

This Associate Director Regulatory Affairs will work on-site out of 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.

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 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.

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 Qualifications

• 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.

Job Family and Division

JOB FAMILY: Regulatory Operations

DIVISION: ADC Diabetes Care

LOCATION: United States > Alameda : 2601 Harbor Bay Parkway

ADDITIONAL LOCATIONS:

Work Shift & Travel

WORK SHIFT: Standard

TRAVEL: Yes, 10 % of the Time

MEDICAL SURVEILLANCE: No

SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

The base pay for this position is $148,700.00 – $297,300.00

In specific locations, the pay range may vary from the range posted.

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.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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 about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews. Follow Us: Facebook LinkedIn YouTube Twitter