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

Responsibilities

Direct development of product registration submission, progress reports, supplements, and amendments as a highly experienced resource
Interact with regulatory agency to expedite approval of pending registration
Serve as regulatory liaison throughout product lifecycle
Participate in and improve processes for product development plan and implementation, regulatory strategy, 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 the approval process through China’s regulatory agency (NMPA) for Abbott’s Cardiac Rhythm Management devices
Work with counterparts located 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 AffairsMedical DevicesHealthcare ComplianceInternational RegulationsDiagnostics

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage in 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.

Is this position remote or onsite?

The position is based at the location in Sylmar, CA.

What are the key responsibilities for this role?

Responsibilities include directing development of product registration submissions, interacting with China's NMPA regulatory agency to expedite approvals, serving as regulatory liaison throughout the product lifecycle, and participating in product development processes.

What is the company culture like at Abbott?

Abbott emphasizes work that matters, career growth, caring for yourself and family, being your true self, and living a full life, and is recognized as a great place to work, one of the most admired companies, and best for diversity, working mothers, female executives, and scientists.

What experience is needed to succeed in this role?

Candidates should be highly experienced and knowledgeable in regulatory affairs, particularly with directing product registration submissions for China’s NMPA, interacting with regulatory agencies, and serving as a liaison for Cardiac Rhythm Management devices.

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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