Senior Regulatory Affairs Specialist - International at Abbott

Sylmar, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Associates Degree (± 13 years)
Minimum 7 years of experience

Responsibilities

Direct development of product registration submission, progress reports, supplements, and amendments as a highly experienced resource
Interact with regulatory agency (NMPA) to expedite approval of pending registrations
Serve as regulatory liaison throughout product lifecycle
Participate in and improve processes for product development plan and implementation, regulatory strategy, and risk management
Ensure timely approval of new medical devices, combination products, and continued approval of marketed products
Serve as regulatory core team representative on product development efforts, and support marketing, research teams, and regulatory agencies
Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations
Oversee approval process through China’s regulatory agency (NMPA) for Abbott’s Cardiac Rhythm Management devices
Work with counterparts in China and act as a liaison between China and US
Provide expert knowledge on regulatory matters

Skills

Key technologies and capabilities for this role

Regulatory AffairsInternational RegulationsMedical DevicesHealthcare ComplianceRegulatory Compliance

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage through the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit for earning a bachelor’s degree.

Is this position remote or on-site?

This is an on-site position located in Sylmar, CA.

What skills are required for the Senior Regulatory Affairs Specialist role?

The role requires high expertise in directing development of product registration submissions, progress reports, supplements, and amendments for China’s NMPA; interacting with regulatory agencies to expedite approvals; and serving as a regulatory liaison throughout the product lifecycle.

What is the company culture like at Abbott?

Abbott fosters a culture where employees can do work that matters, grow, learn, care for themselves and family, be their true selves, and live a full life; it is recognized as a great place to work, one of the most admired companies by Fortune, and best for diversity, working mothers, female executives, and scientists.

What makes a strong candidate for this role?

A strong candidate is highly experienced in regulatory affairs, particularly with China’s NMPA for medical devices, skilled in managing product registration submissions and agency interactions, and able to act as a liaison between US and China teams.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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